Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-22 @ 4:10 AM
Study NCT ID:
NCT01701258
Status:
COMPLETED
Last Update Posted:
2025-05-07
First Post:
2012-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Investigation of Early Life Stress and Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077582', 'term': 'Amisulpride'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dap@mclean.harvard.edu', 'phone': '617-855-4230', 'title': 'Diego Pizzagalli, Ph.D.', 'organization': 'McLean Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The choice of a 50-mg dose of amisulpride was based on animal work showing low doses potentiate striatal dopamine release, have strong hedonic effects, and increase the incentive value of environmental cues. Higher doses may have different results.'}}, 'adverseEventsModule': {'timeFrame': '3 years, 10 months', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'All participants that went through the assessment (session 1) regardless if they were eligible or ineligible.', 'otherNumAtRisk': 153, 'deathsNumAtRisk': 153, 'otherNumAffected': 0, 'seriousNumAtRisk': 153, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'All Baseline Participants', 'description': 'Participants that were eligible for the study after the screening visit (session 1). These participants were invited to participate in the other study sessions.', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 0, 'seriousNumAtRisk': 96, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control Group', 'description': 'Control subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode. These participants were eligible after the screening session (session 1) and are accounted for regardless if they completed other study sessions.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Control-amisulpride (fMRI Session)', 'description': 'After the screening visit, eligible control subjects without a history of child sexual abuse and without a current or past diagnosis of major depression were invited to participate in the fMRI session. Those that were interested, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible baseline control participants did not complete this session.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Control-placebo (fMRI Session)', 'description': 'After the screening visit, eligible control subjects without a history of child sexual abuse and without a current or past diagnosis of major depression were invited to participate in the fMRI session. Those that were interested, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible baseline control participants did not complete this session.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'MDD Group', 'description': 'Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode. These participants were eligible after the screening session (session 1) and are accounted for regardless if they completed other study sessions.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'MDD-amisulpride (fMRI Session)', 'description': 'After the screening visit, eligible subjects without a history of child sexual abuse that are currently experiencing a major depressive episode were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible MDD baseline participants did not complete this session.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'MDD-placebo (fMRI Session)', 'description': 'After the screening visit, eligible subjects without a history of child sexual abuse that are currently experiencing a major depressive episode were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible MDD baseline participants did not complete this session.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'CSA/RES', 'description': 'Subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES). These participants were eligible after the screening session (session 1) and are accounted for regardless if they completed other study sessions.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'CSA/RES-amisulpride (fMRI Session)', 'description': 'After the screening visit, eligible subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.This arm is specific to those that competed the fMRI session. Many eligible CSA/RES baseline participants did not complete this session.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'CSA/RES-placebo (fMRI Session)', 'description': 'After the screening visit, eligible subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible CSA/RES baseline participants did not complete this session.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'CSA/MDD Group', 'description': 'Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA). These participants were eligible after the screening session (session 1) and are accounted for regardless if they completed other study sessions.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'CSA/MDD-amisulpride (fMRI Session)', 'description': 'After the screening visit, eligible subjects with a current episode of major depression (MDD) with a history of child sexual abuse (CSA) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.This arm is specific to those that competed the fMRI session. Many eligible CSA/MDD baseline participants did not complete this session.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG013', 'title': 'CSA/MDD-placebo (fMRI Session)', 'description': 'After the screening visit, eligible subjects with a current episode of major depression (MDD) with a history of child sexual abuse (CSA) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo. This arm is specific to those that competed the fMRI session.\n\nMany eligible CSA/MDD baseline participants did not complete this session.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Other Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dopamine Active Transporter Binding Potential', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.'}, {'id': 'OG001', 'title': 'MDD Group', 'description': 'Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.'}, {'id': 'OG002', 'title': 'CSA/RES Group', 'description': 'Subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES).'}, {'id': 'OG003', 'title': 'CSA/MDD Group', 'description': 'Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.'}], 'classes': [{'title': 'Caudate', 'categories': [{'measurements': [{'value': '3.191', 'spread': '0.124', 'groupId': 'OG000'}, {'value': '3.161', 'spread': '0.139', 'groupId': 'OG001'}, {'value': '3.175', 'spread': '0.130', 'groupId': 'OG002'}, {'value': '3.216', 'spread': '0.136', 'groupId': 'OG003'}]}]}, {'title': 'Putamen', 'categories': [{'measurements': [{'value': '3.361', 'spread': '0.120', 'groupId': 'OG000'}, {'value': '3.359', 'spread': '0.134', 'groupId': 'OG001'}, {'value': '3.241', 'spread': '0.125', 'groupId': 'OG002'}, {'value': '3.318', 'spread': '0.131', 'groupId': 'OG003'}]}]}, {'title': 'Accumbens', 'categories': [{'measurements': [{'value': '2.159', 'spread': '0.109', 'groupId': 'OG000'}, {'value': '2.103', 'spread': '0.122', 'groupId': 'OG001'}, {'value': '2.103', 'spread': '0.122', 'groupId': 'OG002'}, {'value': '2.149', 'spread': '0.119', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour PET scan (Session 3)', 'description': 'Utilizing 11C-altropane during positron emission tomography (PET) scanning allows us to measure dopamine active transporter (DAT) binding potential.\n\nOur outcome measure is Nondisplacable Binding Potential (BPND). BPND refers to the ratio at equilibrium of specifically bound radioligand to that of nondisplaceable radioligand in tissue.\n\n\\*Higher BPND scores indicate greater binding potential', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Effects of CSA and Diagnosis on PRT Performance Under Acute Stress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.'}, {'id': 'OG001', 'title': 'MDD Group', 'description': 'Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.'}, {'id': 'OG002', 'title': 'CSA/RES Group', 'description': 'Subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES).'}, {'id': 'OG003', 'title': 'CSA/MDD Group', 'description': 'Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.'}], 'classes': [{'title': 'PRT Block1: Before MAST', 'categories': [{'measurements': [{'value': '0.028', 'spread': '0.035', 'groupId': 'OG000'}, {'value': '0.117', 'spread': '0.045', 'groupId': 'OG001'}, {'value': '0.092', 'spread': '0.043', 'groupId': 'OG002'}, {'value': '0.167', 'spread': '0.070', 'groupId': 'OG003'}]}]}, {'title': 'PRT Block2: Before MAST', 'categories': [{'measurements': [{'value': '0.124', 'spread': '0.046', 'groupId': 'OG000'}, {'value': '0.155', 'spread': '0.048', 'groupId': 'OG001'}, {'value': '0.130', 'spread': '0.082', 'groupId': 'OG002'}, {'value': '0.168', 'spread': '0.102', 'groupId': 'OG003'}]}]}, {'title': 'PRT Block1: After MAST', 'categories': [{'measurements': [{'value': '0.128', 'spread': '0.026', 'groupId': 'OG000'}, {'value': '0.078', 'spread': '0.055', 'groupId': 'OG001'}, {'value': '0.079', 'spread': '0.042', 'groupId': 'OG002'}, {'value': '0.048', 'spread': '0.042', 'groupId': 'OG003'}]}]}, {'title': 'PRT Block2: After MAST', 'categories': [{'measurements': [{'value': '0.245', 'spread': '0.041', 'groupId': 'OG000'}, {'value': '0.128', 'spread': '0.035', 'groupId': 'OG001'}, {'value': '0.143', 'spread': '0.052', 'groupId': 'OG002'}, {'value': '0.127', 'spread': '0.050', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 hour EEG Session (Session 4)', 'description': "The participant's performance on the Probabilistic Reward Task (PRT) was assessed both before and after an acute stressor. The PRT is a behavioral task that measures an individual's ability to learn from rewarding stimuli and incorporate this learning into their response style (response bias). The acute stressor was the Maastricht Acute Stress Test (MAST). The score obtained is a ratio of the number of times participants correctly choose the high reward stimuli versus the low rewarding stimuli. Response bias scores range between -1 and +1. Higher response bias scores indicate a stronger response bias toward high reward stimuli. A negative response bias indicates a stronger bias toward low reward stimuli.", 'unitOfMeasure': 'Ratio (Response Bias Score)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Effect of Major Depressive Disorder and Childhood Abuse History on a Reward-related EEG Component (Reward Positivity Component) While Under Stress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.'}, {'id': 'OG001', 'title': 'MDD Group', 'description': 'Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.'}, {'id': 'OG002', 'title': 'CSA/RES Group', 'description': 'Subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES).'}, {'id': 'OG003', 'title': 'CSA/MDD Group', 'description': 'Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.'}], 'classes': [{'title': 'Pre MAST', 'categories': [{'measurements': [{'value': '2.71', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '4.75', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '2.16', 'spread': '0.92', 'groupId': 'OG002'}, {'value': '4.15', 'spread': '0.96', 'groupId': 'OG003'}]}]}, {'title': 'Post MAST', 'categories': [{'measurements': [{'value': '2.06', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '4.99', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '2.30', 'spread': '0.98', 'groupId': 'OG002'}, {'value': '3.90', 'spread': '1.01', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 hour EEG Session (Session 4)', 'description': 'EEG was recorded during the probabilistic reward task (the PRT task). Participants completed the Probabilistic Reward Task (PRT) twice throughout the experiment, once before stress and once after stress. The stressor was the Maastricht Acute Stress Test (MAST). This statistic shows the effect that childhood sexual abuse (CSA) and diagnosis had on a reward-related positivity EEG component recorded during the PRT, before and after stress.\n\n* Higher reward positivity amplitudes indicate a stronger neural response to reward and lower amplitudes indicate a lower neural response to rewards.', 'unitOfMeasure': 'amplitude (microvolts)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Cortisol Output in Response to a Stress Manipulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.'}, {'id': 'OG001', 'title': 'MDD Group', 'description': 'Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.'}, {'id': 'OG002', 'title': 'CSA/RES Group', 'description': 'Subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES).'}, {'id': 'OG003', 'title': 'CSA/MDD Group', 'description': 'Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.'}], 'classes': [{'title': 'Cort1', 'categories': [{'measurements': [{'value': '9.80', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '12.53', 'spread': '2.11', 'groupId': 'OG001'}, {'value': '10.15', 'spread': '2.27', 'groupId': 'OG002'}, {'value': '14.19', 'spread': '1.51', 'groupId': 'OG003'}]}]}, {'title': 'Cort2', 'categories': [{'measurements': [{'value': '9.11', 'spread': '2.44', 'groupId': 'OG000'}, {'value': '12.28', 'spread': '1.70', 'groupId': 'OG001'}, {'value': '9.51', 'spread': '1.89', 'groupId': 'OG002'}, {'value': '8.63', 'spread': '0.95', 'groupId': 'OG003'}]}]}, {'title': 'Cort3', 'categories': [{'measurements': [{'value': '15.55', 'spread': '4.91', 'groupId': 'OG000'}, {'value': '15.23', 'spread': '1.65', 'groupId': 'OG001'}, {'value': '10.75', 'spread': '2.19', 'groupId': 'OG002'}, {'value': '14.31', 'spread': '2.15', 'groupId': 'OG003'}]}]}, {'title': 'Cort4', 'categories': [{'measurements': [{'value': '12.89', 'spread': '4.07', 'groupId': 'OG000'}, {'value': '16.30', 'spread': '3.24', 'groupId': 'OG001'}, {'value': '8.99', 'spread': '1.75', 'groupId': 'OG002'}, {'value': '14.22', 'spread': '2.74', 'groupId': 'OG003'}]}]}, {'title': 'Cort5', 'categories': [{'measurements': [{'value': '7.07', 'spread': '1.80', 'groupId': 'OG000'}, {'value': '10.34', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '7.41', 'spread': '1.36', 'groupId': 'OG002'}, {'value': '11.01', 'spread': '2.15', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 hour EEG Session (Session 4)', 'description': "This statistic shows the impact of the stress manipulation on the participant's salivary cortisol output. Saliva samples were collected at 5 distinct time points throughout the study session. The first saliva sample (Cort 1) was collected when the participant began the eeg session. The second (Cort 2)was taken at the end of the acute stressor. The third (Cort 3) was taken approximately fifteen minutes after the second. The fourth (Cort 4) was taken approximately ten minutes after the third. The fifth (Cort 5) was taken approximately 40 minutes after the fourth.", 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Cues', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CSA/MDD-amisulpride', 'description': 'Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.\n\nAmisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only'}, {'id': 'OG001', 'title': 'CSA/MDD-placebo', 'description': 'Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a placebo during the fMRI session.\n\nPlacebo: single-dose placebo capsule during the fMRI session only'}, {'id': 'OG002', 'title': 'CSA/RES-amisulpride', 'description': 'Subjects with a history of child sexual abuse (CSA) without a current or past diagnosis of major depressive disorder (RES) are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.\n\nAmisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only'}, {'id': 'OG003', 'title': 'CSA/RES-placebo', 'description': 'Subjects with a history of child sexual abuse (CSA) without a current or past diagnosis of major depressive disorder (RES) are randomized to receive a placebo during the fMRI session.\n\nPlacebo: single-dose placebo capsule during the fMRI session only'}, {'id': 'OG004', 'title': 'MDD-amisulpride', 'description': 'Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.\n\nAmisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only'}, {'id': 'OG005', 'title': 'MDD-placebo', 'description': 'Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a placebo during the fMRI session.\n\nPlacebo: single-dose placebo capsule during the fMRI session only'}, {'id': 'OG006', 'title': 'Control-amisulpride', 'description': 'Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.\n\nAmisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only'}, {'id': 'OG007', 'title': 'Control-placebo', 'description': 'Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a placebo during the fMRI session.\n\nPlacebo: single-dose placebo capsule during the fMRI session only'}], 'classes': [{'title': 'Caudate Response to Reward Cues', 'categories': [{'measurements': [{'value': '.514', 'spread': '.199', 'groupId': 'OG000'}, {'value': '.054', 'spread': '.238', 'groupId': 'OG001'}, {'value': '.511', 'spread': '.257', 'groupId': 'OG002'}, {'value': '.079', 'spread': '.257', 'groupId': 'OG003'}, {'value': '.403', 'spread': '.209', 'groupId': 'OG004'}, {'value': '.608', 'spread': '.222', 'groupId': 'OG005'}, {'value': '.200', 'spread': '.189', 'groupId': 'OG006'}, {'value': '.468', 'spread': '.189', 'groupId': 'OG007'}]}]}, {'title': 'Caudate Response to Neutral Cues', 'categories': [{'measurements': [{'value': '.254', 'spread': '.161', 'groupId': 'OG000'}, {'value': '-.243', 'spread': '.192', 'groupId': 'OG001'}, {'value': '.050', 'spread': '.208', 'groupId': 'OG002'}, {'value': '-.370', 'spread': '.208', 'groupId': 'OG003'}, {'value': '.047', 'spread': '.170', 'groupId': 'OG004'}, {'value': '.156', 'spread': '.180', 'groupId': 'OG005'}, {'value': '.222', 'spread': '.154', 'groupId': 'OG006'}, {'value': '.185', 'spread': '.154', 'groupId': 'OG007'}]}]}, {'title': 'Putamen Response to Reward Cues', 'categories': [{'measurements': [{'value': '.550', 'spread': '.175', 'groupId': 'OG000'}, {'value': '.468', 'spread': '.209', 'groupId': 'OG001'}, {'value': '.745', 'spread': '.226', 'groupId': 'OG002'}, {'value': '.419', 'spread': '.226', 'groupId': 'OG003'}, {'value': '.698', 'spread': '.185', 'groupId': 'OG004'}, {'value': '.814', 'spread': '.196', 'groupId': 'OG005'}, {'value': '.608', 'spread': '.162', 'groupId': 'OG006'}, {'value': '.663', 'spread': '.167', 'groupId': 'OG007'}]}]}, {'title': 'Putamen Response to Neutral Cues', 'categories': [{'measurements': [{'value': '.550', 'spread': '.175', 'groupId': 'OG000'}, {'value': '.357', 'spread': '.168', 'groupId': 'OG001'}, {'value': '.493', 'spread': '.181', 'groupId': 'OG002'}, {'value': '.240', 'spread': '.181', 'groupId': 'OG003'}, {'value': '.384', 'spread': '.148', 'groupId': 'OG004'}, {'value': '.621', 'spread': '.157', 'groupId': 'OG005'}, {'value': '.455', 'spread': '.134', 'groupId': 'OG006'}, {'value': '.518', 'spread': '.134', 'groupId': 'OG007'}]}]}, {'title': 'Accumbens Response to Reward Cues', 'categories': [{'measurements': [{'value': '.692', 'spread': '.206', 'groupId': 'OG000'}, {'value': '.255', 'spread': '.247', 'groupId': 'OG001'}, {'value': '.679', 'spread': '.267', 'groupId': 'OG002'}, {'value': '.310', 'spread': '.267', 'groupId': 'OG003'}, {'value': '.351', 'spread': '.218', 'groupId': 'OG004'}, {'value': '.428', 'spread': '.231', 'groupId': 'OG005'}, {'value': '.401', 'spread': '.197', 'groupId': 'OG006'}, {'value': '.480', 'spread': '.197', 'groupId': 'OG007'}]}]}, {'title': 'Accumbens Response to Neutral Cues', 'categories': [{'measurements': [{'value': '.385', 'spread': '.173', 'groupId': 'OG000'}, {'value': '.040', 'spread': '.207', 'groupId': 'OG001'}, {'value': '-.123', 'spread': '.224', 'groupId': 'OG002'}, {'value': '-.381', 'spread': '.224', 'groupId': 'OG003'}, {'value': '-.111', 'spread': '.183', 'groupId': 'OG004'}, {'value': '.140', 'spread': '.194', 'groupId': 'OG005'}, {'value': '.016', 'spread': '.165', 'groupId': 'OG006'}, {'value': '.120', 'spread': '.165', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 hour Drug & fMRI Session (Session 2)', 'description': 'This statistic shows the influence of major depressive disorder and childhood sexual abuse history on the strength of striatal activation (caudate, putamen, accumbens) in response to neutral and reward cues during the monetary incentive delay task (MID).\n\nStriatal activation is measured using a statistic called a beta weight. A beta weight is a standardized regression coefficient. Higher beta weights mean greater striatal activation and lower beta weights mean less striatal activation. A negative beta weight would indicate a deactivation.', 'unitOfMeasure': 'beta weight (slope)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Feedback', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'CSA/MDD-amisulpride', 'description': 'Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.\n\nAmisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only'}, {'id': 'OG001', 'title': 'CSA/MDD-placebo', 'description': 'Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a placebo during the fMRI session.\n\nPlacebo: single-dose placebo capsule during the fMRI session only'}, {'id': 'OG002', 'title': 'CSA/RES-amisulpride', 'description': 'Subjects with a history of child sexual abuse (CSA) without a current or past diagnosis of major depressive disorder (RES) are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.\n\nAmisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only'}, {'id': 'OG003', 'title': 'CSA/RES-placebo', 'description': 'Subjects with a history of child sexual abuse (CSA) without a current or past diagnosis of major depressive disorder (RES) are randomized to receive a placebo during the fMRI session.\n\nPlacebo: single-dose placebo capsule during the fMRI session only'}, {'id': 'OG004', 'title': 'MDD-amisulpride', 'description': 'Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.\n\nAmisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only'}, {'id': 'OG005', 'title': 'MDD-placebo', 'description': 'Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a placebo during the fMRI session.\n\nPlacebo: single-dose placebo capsule during the fMRI session only'}, {'id': 'OG006', 'title': 'Control-amisulpride', 'description': 'Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.\n\nAmisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only'}, {'id': 'OG007', 'title': 'Control-placebo', 'description': 'Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a placebo during the fMRI session.\n\nPlacebo: single-dose placebo capsule during the fMRI session only'}], 'classes': [{'title': 'Caudate Response to Reward Feedback', 'categories': [{'measurements': [{'value': '-.101', 'spread': '.329', 'groupId': 'OG000'}, {'value': '.040', 'spread': '.393', 'groupId': 'OG001'}, {'value': '-.197', 'spread': '.425', 'groupId': 'OG002'}, {'value': '-.905', 'spread': '.425', 'groupId': 'OG003'}, {'value': '-.819', 'spread': '.347', 'groupId': 'OG004'}, {'value': '-.773', 'spread': '.368', 'groupId': 'OG005'}, {'value': '-.613', 'spread': '.314', 'groupId': 'OG006'}, {'value': '-.273', 'spread': '.314', 'groupId': 'OG007'}]}]}, {'title': 'Caudate Response to Neutral Feedback', 'categories': [{'measurements': [{'value': '-.233', 'spread': '.314', 'groupId': 'OG000'}, {'value': '-.608', 'spread': '.376', 'groupId': 'OG001'}, {'value': '-.501', 'spread': '.406', 'groupId': 'OG002'}, {'value': '-.959', 'spread': '.406', 'groupId': 'OG003'}, {'value': '-.865', 'spread': '.331', 'groupId': 'OG004'}, {'value': '-.733', 'spread': '.352', 'groupId': 'OG005'}, {'value': '-.793', 'spread': '.300', 'groupId': 'OG006'}, {'value': '-.105', 'spread': '.300', 'groupId': 'OG007'}]}]}, {'title': 'Putamen Response to Reward Feedback', 'categories': [{'measurements': [{'value': '-.018', 'spread': '.217', 'groupId': 'OG000'}, {'value': '.063', 'spread': '.260', 'groupId': 'OG001'}, {'value': '-.087', 'spread': '.281', 'groupId': 'OG002'}, {'value': '-.304', 'spread': '.281', 'groupId': 'OG003'}, {'value': '-.031', 'spread': '.229', 'groupId': 'OG004'}, {'value': '-.357', 'spread': '.243', 'groupId': 'OG005'}, {'value': '-.533', 'spread': '.207', 'groupId': 'OG006'}, {'value': '-.131', 'spread': '.207', 'groupId': 'OG007'}]}]}, {'title': 'Putamen Response to Neutral Feedback', 'categories': [{'measurements': [{'value': '-.021', 'spread': '.201', 'groupId': 'OG000'}, {'value': '-.418', 'spread': '.240', 'groupId': 'OG001'}, {'value': '-.142', 'spread': '.260', 'groupId': 'OG002'}, {'value': '-.276', 'spread': '.260', 'groupId': 'OG003'}, {'value': '-.229', 'spread': '.221', 'groupId': 'OG004'}, {'value': '-.108', 'spread': '.225', 'groupId': 'OG005'}, {'value': '-.375', 'spread': '.192', 'groupId': 'OG006'}, {'value': '.164', 'spread': '.192', 'groupId': 'OG007'}]}]}, {'title': 'Accumbens Response to Reward Feedback', 'categories': [{'measurements': [{'value': '-.158', 'spread': '.421', 'groupId': 'OG000'}, {'value': '.839', 'spread': '.503', 'groupId': 'OG001'}, {'value': '-.046', 'spread': '.544', 'groupId': 'OG002'}, {'value': '-.713', 'spread': '.544', 'groupId': 'OG003'}, {'value': '-.554', 'spread': '.444', 'groupId': 'OG004'}, {'value': '-.215', 'spread': '.471', 'groupId': 'OG005'}, {'value': '.074', 'spread': '.401', 'groupId': 'OG006'}, {'value': '.069', 'spread': '.401', 'groupId': 'OG007'}]}]}, {'title': 'Accumbens Response to Neutral Feedback', 'categories': [{'measurements': [{'value': '.010', 'spread': '.308', 'groupId': 'OG000'}, {'value': '-.332', 'spread': '.368', 'groupId': 'OG001'}, {'value': '-.079', 'spread': '.398', 'groupId': 'OG002'}, {'value': '-.819', 'spread': '.398', 'groupId': 'OG003'}, {'value': '-.456', 'spread': '.325', 'groupId': 'OG004'}, {'value': '-.039', 'spread': '.345', 'groupId': 'OG005'}, {'value': '-.503', 'spread': '.294', 'groupId': 'OG006'}, {'value': '.109', 'spread': '.294', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 hour Session 2 (fMRI session)', 'description': 'This statistic shows the influence of major depressive disorder and childhood sexual abuse history on the strength of striatal activation (caudate, putamen, accumbens) in response to neutral and reward feedback during the monetary incentive delay task (MID).\n\nStriatal activation is measured using a statistic called a beta weight. A beta weight is a standardized regression coefficient. Higher beta weights mean greater striatal activation and lower beta weights mean less striatal activation. A negative beta weight would indicate a deactivation.', 'unitOfMeasure': 'beta weight (slope)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Effect of Diagnosis on Cortisol Reactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.'}, {'id': 'OG001', 'title': 'MDD Group', 'description': 'Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.'}, {'id': 'OG002', 'title': 'CSA/RES Group', 'description': 'Subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES).'}, {'id': 'OG003', 'title': 'CSA/MDD Group', 'description': 'Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.'}], 'classes': [{'categories': [{'measurements': [{'value': '156.58', 'spread': '10.72', 'groupId': 'OG000'}, {'value': '186.78', 'spread': '12.20', 'groupId': 'OG001'}, {'value': '152.13', 'spread': '12.20', 'groupId': 'OG002'}, {'value': '179.16', 'spread': '11.25', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 hour EEG Session (Session 4)', 'description': 'This is a measure of area under the curve in relation to ground, a measure of total cortisol output, in response to acute stress. The acute stressor was the Maastricht Acute Stress Test (MAST). The area under the curve includes all 5 cortisol measures, with one measure before the stressor and the other four measures collected after the stressor. Given that the cortisol data were positively skewed, the cortisol measures were normalized via a log transformation prior to calculating the area under the curve.\n\nArea under the curve with respect to ground (AUCG) is calculated AUC\\_g=(((cort2\\_log + cort1\\_log) \\* cort\\_t1\\_time) / 2)+(((cort3\\_log+cort2\\_log)\\*cort\\_t2\\_time)/2)+(((cort4\\_log+cort3\\_log)\\*cort\\_t3\\_time)/2)+(((cort5\\_log+cort4\\_log)\\*cort\\_t4\\_time)/2). Cort\\_logs are the log transformed cortisol output data (ng/ml) and the cort\\_times are the time spans in between each cortisol assessment.', 'unitOfMeasure': '[log (ng/ml)]*min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'All participants that went through the assessment (session 1) regardless if they were eligible or ineligible.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.'}, {'id': 'FG002', 'title': 'Control-amisulpride (fMRI Session)', 'description': 'After the screening visit, eligible control subjects without a history of child sexual abuse and without a current or past diagnosis of major depression were invited to participate in the fMRI session. Those that were interested were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible baseline control participants did not complete this session.'}, {'id': 'FG003', 'title': 'Control-placebo (fMRI Session)', 'description': 'After the screening visit, eligible control subjects without a history of child sexual abuse and without a current or past diagnosis of major depression were invited to participate in the fMRI session. Those that were interested were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible baseline control participants did not complete this session.'}, {'id': 'FG004', 'title': 'MDD Group', 'description': 'Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode .'}, {'id': 'FG005', 'title': 'MDD-amisulpride (fMRI Session)', 'description': 'After the screening visit, eligible subjects without a history of child sexual abuse that are currently experiencing a major depressive episode were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible MDD baseline participants did not complete this session.'}, {'id': 'FG006', 'title': 'MDD-placebo (fMRI Session)', 'description': 'After the screening visit, eligible subjects without a history of child sexual abuse that are currently experiencing a major depressive episode were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible MDD baseline participants did not complete this session.'}, {'id': 'FG007', 'title': 'CSA/RES', 'description': 'Subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES).'}, {'id': 'FG008', 'title': 'CSA/RES-amisulpride (fMRI Session)', 'description': 'After the screening visit, eligible subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.This arm is specific to those that competed the fMRI session. Many eligible CSA/RES baseline participants did not complete this session.'}, {'id': 'FG009', 'title': 'CSA/RES-placebo (fMRI Session)', 'description': 'After the screening visit, eligible subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible CSA/RES baseline participants did not complete this session.'}, {'id': 'FG010', 'title': 'CSA/MDD Group', 'description': 'Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA).'}, {'id': 'FG011', 'title': 'CSA/MDD-amisulpride (fMRI Session)', 'description': 'After the screening visit, eligible subjects with a current episode of major depression (MDD) with a history of child sexual abuse (CSA) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.This arm is specific to those that competed the fMRI session. Many eligible CSA/MDD baseline participants did not complete this session.'}, {'id': 'FG012', 'title': 'CSA/MDD-placebo (fMRI Session)', 'description': 'After the screening visit, eligible subjects with a current episode of major depression (MDD) with a history of child sexual abuse (CSA) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo. This arm is specific to those that competed the fMRI session.\n\nMany eligible CSA/MDD baseline participants did not complete this session.'}], 'periods': [{'title': 'Assessment and Scheduling', 'milestones': [{'type': 'STARTED', 'comment': '153 individuals were enrolled in the study. 96 were eligible after the screening visit.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Eligible After Screening Visit', 'comment': '96 participants were eligible after the screening visit. These were our baseline participants.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Returned for Drug+fMRI (Session 2)', 'comment': '68 out of the 96 eligible participants completed the MRI.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Returned for PET (Session 3)', 'comment': "73 /96 eligible completed the PET. They didn't need to complete the the MRI to complete the PET.", 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Returned for EEG (Session 4)', 'comment': '66/96 completed the EEG. Participants did at least two sessions after the screening visit.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Participants completed the study if they completed the screening session and two imaging sessions.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Found to be Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Investigator Terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'Drug+fMRI (Session 2)', 'milestones': [{'type': 'STARTED', 'comment': 'Eligible participants after the screening session were invited to participate in this session.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '10'}, {'groupId': 'FG012', 'numSubjects': '7'}]}, {'type': 'Received Drug Challenge', 'comment': 'Not all participants that were eligible completed the MRI.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '10'}, {'groupId': 'FG012', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '10'}, {'groupId': 'FG012', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'PET (Session 3)', 'milestones': [{'type': 'STARTED', 'comment': 'Not all participants that were eligible or completed the MRI completed the PET.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '19'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '18'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '19'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '18'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'EEG (Session 4)', 'milestones': [{'type': 'STARTED', 'comment': 'Not all participants that were eligible or completed the MRI/PET completed the EEG.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '16'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '17'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '16'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '17'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited at McLean Hospital (Belmont, MA) between August, 2013, and June, 2017. The study was advertised using flyers, and on a number of internet bulletin boards available to the general public. Study visits were conducted in research facilities at McLean Hospital and Massachusetts General Hospital.', 'preAssignmentDetails': 'In session 1, subjects had a diagnostic interview, a physical exam, provided a blood sample, and completed surveys, to determine eligibility. Those eligible were invited to participate in the other sessions. Participants did not need to complete all sessions. The order depended on facility availability and convenience for participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.'}, {'id': 'BG001', 'title': 'MDD Group', 'description': 'Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.'}, {'id': 'BG002', 'title': 'CSA/RES Group', 'description': 'Subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES).'}, {'id': 'BG003', 'title': 'CSA/MDD Group', 'description': 'Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.44', 'spread': '6.64', 'groupId': 'BG000'}, {'value': '27.19', 'spread': '5.99', 'groupId': 'BG001'}, {'value': '25.61', 'spread': '4.94', 'groupId': 'BG002'}, {'value': '29.95', 'spread': '6.91', 'groupId': 'BG003'}, {'value': '26.63', 'spread': '6.08', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BDI II', 'classes': [{'categories': [{'measurements': [{'value': '1.68', 'spread': '2.79', 'groupId': 'BG000'}, {'value': '27.23', 'spread': '8.44', 'groupId': 'BG001'}, {'value': '3.83', 'spread': '5.77', 'groupId': 'BG002'}, {'value': '31.49', 'spread': '9.05', 'groupId': 'BG003'}, {'value': '15.95', 'spread': '15.14', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Measure Description: Beck Depression Inventory-II (BDI-II). Measures the presence and severity of 21 depressive symptoms during the past two weeks, on a scale from 0 (none, or no change) to 3 (persistent, or worsening).Range: 0 to 63. Higher scores indicate greater symptom severity. Clinical categories for total score: 0-14: absent; 14-19: mild; 20-28: moderate; 29-63: severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'MASQ total', 'classes': [{'categories': [{'measurements': [{'value': '93.04', 'spread': '16.27', 'groupId': 'BG000'}, {'value': '167.86', 'spread': '22.60', 'groupId': 'BG001'}, {'value': '101.82', 'spread': '26.19', 'groupId': 'BG002'}, {'value': '180.57', 'spread': '21.89', 'groupId': 'BG003'}, {'value': '135.42', 'spread': '44.65', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Measure Description: Mood and Anxiety Symptom Questionnaire (MASQ), short form. Measures the severity of anxiety and depressive symptoms.62 items, rating of how much you have experienced certain feelings, emotions, or behaviors in the past week; item responses are on a 5-point scale from 1 (not at all) to 5 (extremely).\n\nRange: 62-310; higher scores indicates more severe symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Our baseline population are the 96 individuals that were eligible for the study after the screening visit. Not all participants that were eligible after the screening visit went on to participate in the other study sessions. Baseline data were collected for all eligible participants in each cohort during the assessment and scheduling period.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-20', 'size': 938574, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-05-08T12:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There were four groups of subjects: those with a history of child sexual abuse that are currently experiencing a major depressive episode, those with a history of child sexual abuse without a current or past diagnosis of major depressive disorder, those without a history of child sexual abuse that are currently experiencing a major depressive episode, and those with without a history of child sexual abuse and without a current or past diagnosis of major depressive disorder. Within each group, half of the subjects were assigned to receive the study drug (amisulpride) and half to receive a placebo for the fMRI session (session 2 or 3).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2012-10-02', 'resultsFirstSubmitDate': '2018-03-21', 'studyFirstSubmitQcDate': '2012-10-03', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-16', 'studyFirstPostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dopamine Active Transporter Binding Potential', 'timeFrame': '1 hour PET scan (Session 3)', 'description': 'Utilizing 11C-altropane during positron emission tomography (PET) scanning allows us to measure dopamine active transporter (DAT) binding potential.\n\nOur outcome measure is Nondisplacable Binding Potential (BPND). BPND refers to the ratio at equilibrium of specifically bound radioligand to that of nondisplaceable radioligand in tissue.\n\n\\*Higher BPND scores indicate greater binding potential'}, {'measure': 'The Effects of CSA and Diagnosis on PRT Performance Under Acute Stress', 'timeFrame': '3 hour EEG Session (Session 4)', 'description': "The participant's performance on the Probabilistic Reward Task (PRT) was assessed both before and after an acute stressor. The PRT is a behavioral task that measures an individual's ability to learn from rewarding stimuli and incorporate this learning into their response style (response bias). The acute stressor was the Maastricht Acute Stress Test (MAST). The score obtained is a ratio of the number of times participants correctly choose the high reward stimuli versus the low rewarding stimuli. Response bias scores range between -1 and +1. Higher response bias scores indicate a stronger response bias toward high reward stimuli. A negative response bias indicates a stronger bias toward low reward stimuli."}, {'measure': 'The Effect of Major Depressive Disorder and Childhood Abuse History on a Reward-related EEG Component (Reward Positivity Component) While Under Stress', 'timeFrame': '3 hour EEG Session (Session 4)', 'description': 'EEG was recorded during the probabilistic reward task (the PRT task). Participants completed the Probabilistic Reward Task (PRT) twice throughout the experiment, once before stress and once after stress. The stressor was the Maastricht Acute Stress Test (MAST). This statistic shows the effect that childhood sexual abuse (CSA) and diagnosis had on a reward-related positivity EEG component recorded during the PRT, before and after stress.\n\n* Higher reward positivity amplitudes indicate a stronger neural response to reward and lower amplitudes indicate a lower neural response to rewards.'}, {'measure': 'Cortisol Output in Response to a Stress Manipulation', 'timeFrame': '3 hour EEG Session (Session 4)', 'description': "This statistic shows the impact of the stress manipulation on the participant's salivary cortisol output. Saliva samples were collected at 5 distinct time points throughout the study session. The first saliva sample (Cort 1) was collected when the participant began the eeg session. The second (Cort 2)was taken at the end of the acute stressor. The third (Cort 3) was taken approximately fifteen minutes after the second. The fourth (Cort 4) was taken approximately ten minutes after the third. The fifth (Cort 5) was taken approximately 40 minutes after the fourth."}, {'measure': 'Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Cues', 'timeFrame': '3 hour Drug & fMRI Session (Session 2)', 'description': 'This statistic shows the influence of major depressive disorder and childhood sexual abuse history on the strength of striatal activation (caudate, putamen, accumbens) in response to neutral and reward cues during the monetary incentive delay task (MID).\n\nStriatal activation is measured using a statistic called a beta weight. A beta weight is a standardized regression coefficient. Higher beta weights mean greater striatal activation and lower beta weights mean less striatal activation. A negative beta weight would indicate a deactivation.'}, {'measure': 'Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Feedback', 'timeFrame': '3 hour Session 2 (fMRI session)', 'description': 'This statistic shows the influence of major depressive disorder and childhood sexual abuse history on the strength of striatal activation (caudate, putamen, accumbens) in response to neutral and reward feedback during the monetary incentive delay task (MID).\n\nStriatal activation is measured using a statistic called a beta weight. A beta weight is a standardized regression coefficient. Higher beta weights mean greater striatal activation and lower beta weights mean less striatal activation. A negative beta weight would indicate a deactivation.'}, {'measure': 'The Effect of Diagnosis on Cortisol Reactivity', 'timeFrame': '3 hour EEG Session (Session 4)', 'description': 'This is a measure of area under the curve in relation to ground, a measure of total cortisol output, in response to acute stress. The acute stressor was the Maastricht Acute Stress Test (MAST). The area under the curve includes all 5 cortisol measures, with one measure before the stressor and the other four measures collected after the stressor. Given that the cortisol data were positively skewed, the cortisol measures were normalized via a log transformation prior to calculating the area under the curve.\n\nArea under the curve with respect to ground (AUCG) is calculated AUC\\_g=(((cort2\\_log + cort1\\_log) \\* cort\\_t1\\_time) / 2)+(((cort3\\_log+cort2\\_log)\\*cort\\_t2\\_time)/2)+(((cort4\\_log+cort3\\_log)\\*cort\\_t3\\_time)/2)+(((cort5\\_log+cort4\\_log)\\*cort\\_t4\\_time)/2). Cort\\_logs are the log transformed cortisol output data (ng/ml) and the cort\\_times are the time spans in between each cortisol assessment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression', 'Childhood Sexual Abuse', 'Dopamine', 'MRI', 'PET', 'ERP', 'Stress', 'Reward', 'Childhood trauma', 'Amisulpride'], 'conditions': ['Major Depressive Disorder (MDD)', 'History of Childhood Sexual Abuse (CSA)']}, 'referencesModule': {'references': [{'pmid': '28942738', 'type': 'RESULT', 'citation': 'Kaiser RH, Clegg R, Goer F, Pechtel P, Beltzer M, Vitaliano G, Olson DP, Teicher MH, Pizzagalli DA. Childhood stress, grown-up brain networks: corticolimbic correlates of threat-related early life stress and adult stress response. Psychol Med. 2018 May;48(7):1157-1166. doi: 10.1017/S0033291717002628. Epub 2017 Sep 25.'}, {'pmid': '31784354', 'type': 'DERIVED', 'citation': 'Liu Y, Admon R, Mellem MS, Belleau EL, Kaiser RH, Clegg R, Beltzer M, Goer F, Vitaliano G, Ahammad P, Pizzagalli DA. Machine Learning Identifies Large-Scale Reward-Related Activity Modulated by Dopaminergic Enhancement in Major Depression. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Feb;5(2):163-172. doi: 10.1016/j.bpsc.2019.10.002. Epub 2019 Oct 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate brain pathways within adult females (with a history of CSA that occurred between the ages of 5-14) with and without a current diagnosis of major depressive disorder (MDD).\n\nHypotheses:\n\nThe CSA/MDD participants will be characterized by (1) reduced reward responsiveness and prefrontal cortex activity, but increased cortisol levels, (2) reduced dopamine activity, and (3) reduced dopamine transporter binding. The over-arching purpose of the study is to (1) identify individuals at risk for psychopathology and maladaptive behavior, (2) prevent re-victimization, and (3) develop more targeted therapeutic interventions.', 'detailedDescription': 'This study will include four sessions:\n\nSession 1 (SCID Session) The first session takes place at the Center for Depression, Anxiety, and Stress Research (CDASR) or Neuroimaging Center (both at McLean Hospital) and involves consenting, a clinical evaluation, a series of questionnaires, and a medical assessment.\n\nSession 2 or 3 (fMRI Session) The third session takes place at the Neuroimaging Center. Using a double-blind design, participants will be administered either amisulpride (50 mg) or placebo. Participants will complete the Monetary Incentive Delay (MID) task during functional magnetic resonance imaging (fMRI) and the Probabilistic Stimulus Selection Task (PSST) afterwards.\n\nSession 2 or 3 (PET Session) This session takes place at Massachusetts General Hospital. 9 mCi of \\[11C\\] altropane will be injected by a trained nuclear medicine technician and positron emission tomography (PET) scanning will begin. Prior to the PET scan, a blood serum pregnancy test will be administered for females.\n\nSession 4 (ERP Session) The fourth session takes place at the CDASR and involves an electroencephalography (EEG) recording, the Probabilistic Reward Task (PRT), and collecting saliva samples to assess cortisol levels.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'General Inclusion Criteria:\n\n* Females of all ethnic origins, age between 20 and 45; right-handed (Chapman \\& Chapman 1987);\n* Absence of any psychotropic medications for at least 2 weeks (6 weeks for fluoxetine; 6 months for neuroleptics; 2 weeks for benzodiazepines; 2 weeks for any other antidepressants);\n\nInclusion Criteria for Childhood Sexual Abuse/MDD (CSA/MDD) Group:\n\n* At least one incident of contact sexual abuse1 between the ages 5-14 years;\n* Current DSM-IV diagnostic criteria for MDD (as diagnosed with the use of the SCID);\n\nInclusion Criteria for Childhood Sexual Abuse/Resilient (CSA/RES) Group:\n\n* At least one incident of contact sexual abuse1 between the ages 5-14 years;\n* Absence of past or current DSM diagnosis, including MDD or alcohol/substance abuse;\n\nInclusion Criteria for Non-traumatized, MDD (MDD) Group:\n\n* No incidents of sexual, verbal, or physical abuse (ascertained using the Traumatic Antecedents Questionnaire);\n* Current DSM-IV diagnostic criteria for MDD (as diagnosed with the use of SCID);\n\nNon-traumatized, healthy controls (controls):\n\n* No incidents of sexual, verbal, or physical abuse (ascertained using the Traumatic Antecedents Questionnaire);\n* Absence of any medical, neurological, and psychiatric illness (including alcohol/substance abuse)\n\nExclusion Criteria:\n\n* Participants with suicidal ideation where study participation is deemed unsafe by the study clinician;\n* Pregnant women or women of childbearing potential who are not compliant with the requirements of a urine and blood pregnancy test.\n* Failure to meet MRI or PET safety requirements.\n* Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine (hypothyroidism), neurologic or hematologic disease;\n* Past/current DSM diagnosis of: OCD, ADHD, schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder, mood congruent/incongruent psychotic features, substance dependence, substance abuse within the last 12 months (with the exception of cocaine or stimulant abuse, which will lead to automatic exclusion);\n* Simple phobia, social anxiety disorder and generalized anxiety disorders will be allowed only if secondary to MDD and only in the CSA/MDD and MDD groups (which will be matched for comorbidities);\n* History of seizure disorder; renal insufficiency; history of adverse reactions to amisulpride;\n* History of cocaine, stimulant, and other DA drug use \\[e.g., (meth)amphetamine), methylphenidate\\].'}, 'identificationModule': {'nctId': 'NCT01701258', 'briefTitle': 'An Investigation of Early Life Stress and Depression', 'organization': {'class': 'OTHER', 'fullName': 'Mclean Hospital'}, 'officialTitle': 'Early Life Stress and Depression: Molecular and Functional Imaging Approaches', 'orgStudyIdInfo': {'id': '2012P002593'}, 'secondaryIdInfos': [{'id': '5R01MH095809', 'link': 'https://reporter.nih.gov/quickSearch/5R01MH095809', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CSA/MDD-amisulpride', 'description': 'Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.', 'interventionNames': ['Drug: Amisulpride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CSA/MDD-placebo', 'description': 'Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a placebo during the fMRI session.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CSA/RES-amisulpride', 'description': 'Subjects with a history of child sexual abuse (CSA) without a current or past diagnosis of major depressive disorder (RES) are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.', 'interventionNames': ['Drug: Amisulpride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CSA/RES-placebo', 'description': 'Subjects with a history of child sexual abuse (CSA) without a current or past diagnosis of major depressive disorder (RES) are randomized to receive a placebo during the fMRI session.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MDD-amisulpride', 'description': 'Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.', 'interventionNames': ['Drug: Amisulpride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'MDD-placebo', 'description': 'Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a placebo during the fMRI session.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control-amisulpride', 'description': 'Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.', 'interventionNames': ['Drug: Amisulpride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control-placebo', 'description': 'Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a placebo during the fMRI session.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Amisulpride', 'type': 'DRUG', 'otherNames': ['Solian'], 'description': 'single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only', 'armGroupLabels': ['CSA/MDD-amisulpride', 'CSA/RES-amisulpride', 'Control-amisulpride', 'MDD-amisulpride']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'single-dose placebo capsule during the fMRI session only', 'armGroupLabels': ['CSA/MDD-placebo', 'CSA/RES-placebo', 'Control-placebo', 'MDD-placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02478', 'city': 'Belmont', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'McLean Hospital', 'geoPoint': {'lat': 42.39593, 'lon': -71.17867}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Diego Pizzagalli, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mclean Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mclean Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychiatry, Harvard Medical School', 'investigatorFullName': 'Diego Pizzagalli', 'investigatorAffiliation': 'Mclean Hospital'}}}}