Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT04697693
Status:
TERMINATED
Last Update Posted:
2022-05-11
First Post:
2021-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Antidepressant Response in Older Adults With Comorbid PTSD and MDD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089983', 'term': 'Escitalopram'}, {'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bret.rutherford@nyspi.columbia.edu', 'phone': '646-774-8660', 'title': 'Dr. Bret Rutherford', 'organization': 'New York State Psychiatric Institute'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The study had a planned accrual of 25 participants but only accrued 1 participant due to challenges in recruiting during the pandemic.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected over the period of 8 weeks.', 'description': 'Subjects will have telephone/video-conference visits via a telephone and/or a HIPAA compliant video conferencing platform, Webex with the research assistant and study clinician every two weeks. If the participant requests or significant clinical worsening in the judgement of the study clinician occurs, then the participant will be brought to NYSPI for in person evaluation.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment With Escitalopram or Duloxetine', 'description': 'Participant will be begun on either escitalopram 10mg or duloxetine 30mg. The default medication will be escitalopram. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the Hamilton Rating Score for Depression (HRSD) \\>7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study. Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg of duloxetine for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study.\n\nEscitalopram: The participant will be begun on either escitalopram 10mg or duloxetine 30mg. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the HRSD \\>7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study.\n\nDuloxetine: Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg of duloxetine for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Hamilton Rating Score for Depression (HRSD) From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Escitalopram or Duloxetine', 'description': 'Participant will be begun on either escitalopram 10mg or duloxetine 30mg. The default medication will be escitalopram. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the Hamilton Rating Score for Depression (HRSD) \\>7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study. Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg of duloxetine for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study.\n\nEscitalopram: The participant will be begun on either escitalopram 10mg or duloxetine 30mg. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the HRSD \\>7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study.\n\nDuloxetine: Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg of duloxetine for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': 'NA', 'comment': 'Total number of enrolled participants is one, so standard deviation cannot be calculated.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. The change in Hamilton Rating Score for Depression (HRSD) from baseline to week 8 was calculated as Week 8 HRSD - Baseline HRSD.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment With Escitalopram or Duloxetine', 'description': 'Participant will be begun on either escitalopram 10mg or duloxetine 30mg. The default medication will be escitalopram. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the Hamilton Rating Score for Depression (HRSD) \\>7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study. Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg of duloxetine for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study.\n\nEscitalopram: The participant will be begun on either escitalopram 10mg or duloxetine 30mg. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the HRSD \\>7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study.\n\nDuloxetine: Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg of duloxetine for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment With Escitalopram or Duloxetine', 'description': 'Participant will be begun on either escitalopram 10mg or duloxetine 30mg. The default medication will be escitalopram. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the Hamilton Rating Score for Depression (HRSD) \\>7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study. Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg of duloxetine for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study.\n\nEscitalopram: he participant will be begun on either escitalopram 10mg or duloxetine 30mg. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the HRSD \\>7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study.\n\nDuloxetine: Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg of duloxetine for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data are not available to be reported due to patient privacy concerns.', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hamilton Rating Score for Depression (HRSD)', 'classes': [{'categories': [{'measurements': [{'value': '23', 'spread': 'NA', 'comment': 'Total number of enrolled participants is one, so standard deviation cannot be calculated.', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Scale for depressive symptoms administered by trained rater. The Hamilton is the standard measure of depression severity for clinical trials of antidepressants and was chosen to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. The scoring is based on the first 24 items of the Hamilton.\n\nSum of the scores of the first 24 items (range from 0 to 74):\n\n0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression \\>=23 = Very Severe Depression', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-31', 'size': 649775, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2022-02-17T11:11', 'hasProtocol': True}, {'date': '2021-01-29', 'size': 74436, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-02-18T11:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Unable to recruit participants in a timely fashion due to COVID pandemic', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-12', 'studyFirstSubmitDate': '2021-01-04', 'resultsFirstSubmitDate': '2022-03-01', 'studyFirstSubmitQcDate': '2021-01-05', 'lastUpdatePostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-01', 'studyFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hamilton Rating Score for Depression (HRSD) From Baseline to Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. The change in Hamilton Rating Score for Depression (HRSD) from baseline to week 8 was calculated as Week 8 HRSD - Baseline HRSD.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Traumatic Stress Disorder', 'Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': "In the Investigator's ongoing studies of Posttraumatic Stress Disorder (PTSD) in older adults, it has been found that older adults with PTSD frequently meet the criteria for comorbid Major Depressive Disorder (MDD). Moreover, relative to trauma-exposed healthy controls (TEHCs), elders with PTSD manifest executive function deficits, fatigability, and mobility and physical function deficits that are consistent with what the investigator has observed in depressed older adults. Yet, the investigator has found that very few older adults with combined PTSD/MDD have received appropriate antidepressant treatment for their condition. These findings give rise to the questions of (1) how effective is antidepressant treatment for depressive symptoms in the context of PTSD/MDD and (2) are cognitive and physical function deficits in PTSD/MDD patients reversible with effective antidepressant treatment?", 'detailedDescription': 'Chronic PTSD in older adults leads to increased risk of mortality from cardiovascular disease, metabolic syndrome, diabetes mellitus, and ulcerative gastrointestinal disease. PTSD appears to promote aging-associated syndromes such as frailty, and older patients with PTSD exhibit faster cognitive decline and have twice the risk of dementia compared to individuals without PTSD. In addition, laboratory studies report accelerated biological signatures of aging in PTSD patients, including shortened leukocyte telomere length, increases in pro-inflammatory cytokines, and increased oxidative stress. PTSD is associated with similar anatomical brain changes to those occurring with cognitive aging, including bilateral hippocampal volume reductions, specifically affecting the dentate gyrus (DG) and CA3 subregion, and increased microvascular lesions (white matter hyperintensities \\[WMH\\]). These observations suggest that the adverse health and functional outcomes associated with chronic PTSD in older patients may be explained by a deleterious interaction between pathophysiologic changes underlying PTSD and the biology of aging, the end result of which is to accelerate senescence throughout the body and particularly in the brain. However, no prior study has explicitly tested this hypothesis by examining indices of aging in older adults with and without PTSD. In our ongoing IRB #7489, The investigator hypothesize that chronic PTSD, over and above other contributing factors, accelerates biological aging in the brain and body, leading to adverse behavioral consequences such as frailty and cognitive decline. To test these hypotheses, 150 individuals are being recruited who are agedā„50and diagnosed with PTSD. A control group of 150 age-, sex-, and trauma exposure-matched subjects without PTSD are being recruited and assessed. Included subjects undergo comprehensive neuropsychological assessment and cerebral blood volume functional magnetic resonance imaging (CBV-fMRI) to assess regional hippocampal metabolic activity and function. Structural MRI is performed to quantify WMH, regional brain volume, and cortical thickness while resting-state fMRI measures functional connectivity within hippocampal networks. PTSD subjects and controls are compared on measures of aging within the following domains: neural (DG CBV, WMH, morphology), cognitive (processing speed, memory, executive function, pattern separation), somatic (peripheral inflammatory markers, leukocyte telomere length, and measures of oxidative stress), and behavioral (grip strength, gait speed, fatigue levels). By elucidating the interaction of chronic PTSD with aging processes, data from this project may contribute to the development of rationally designed, personalized, and age-appropriate novel treatments.\n\nInterim analyses of PTSD subjects in this study demonstrate a high degree of comorbidity with MDD. Among participants with PTSD enrolled to date, 67.1% meet the criteria for MDD and the mean Hamilton Rating Scale for Depression (HRSD) is 18.1. The most prominent cognitive differences observed to date in our study between PTSD and TEHC subjects is executive dysfunction, which is common in late-life depression.\n\nPTSD subjects have dramatically increased fatigability and prevalence of frailty criteria compared to TEHCs, abnormalities which are also frequently seen in our older MDD samples. Yet, the investigator has found that less than 25% of these individuals are currently receiving an adequate dose and duration of first-line pharmacotherapy for MDD, while only one-third report any past medication treatment. These data raise the question of whether patients with combined PTSD/MDD could benefit from adequate antidepressant medication treatment and to what degree their cognitive and physical function deficits would be reversible with this therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Individual has completed IRB 7489\n2. Diagnosed with DSM 5 MDD\n3. HRSD \\>=18\n4. Willing to and capable of providing informed consent and complying with study procedures.\n\nExclusion Criteria:\n\n1. History of allergic or adverse reaction to\n2. Non-response to adequate trial of escitalopram (at least 4 weeks at dose of 20mg) and duloxetine (at least 4 weeks at dose of 60mg)during the current episode.\n3. Current treatment with psychotherapy, antidepressants, or other psychotropic medications.'}, 'identificationModule': {'nctId': 'NCT04697693', 'briefTitle': 'Antidepressant Response in Older Adults With Comorbid PTSD and MDD', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'Antidepressant Response in Older Adults With Comorbid PTSD and MDD', 'orgStudyIdInfo': {'id': '8111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with escitalopram or duloxetine', 'description': 'Participant will be begun on either escitalopram 10mg or duloxetine 30mg. The default medication will be escitalopram. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the Hamilton Rating Score for Depression (HRSD) \\>7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study. Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg of duloxetine for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study', 'interventionNames': ['Drug: Escitalopram', 'Drug: Duloxetine']}], 'interventions': [{'name': 'Escitalopram', 'type': 'DRUG', 'otherNames': ['lexapro'], 'description': 'The participant will be begun on either escitalopram 10mg or duloxetine 30mg. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the HRSD \\>7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study.', 'armGroupLabels': ['Treatment with escitalopram or duloxetine']}, {'name': 'Duloxetine', 'type': 'DRUG', 'otherNames': ['cymbalta'], 'description': 'Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study.', 'armGroupLabels': ['Treatment with escitalopram or duloxetine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York State Psychiatric Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Bret R Rutherford, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York State Psychiatric Institue'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Clinical Psychiatry', 'investigatorFullName': 'Bret Rutherford', 'investigatorAffiliation': 'New York State Psychiatric Institute'}}}}