Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT01066156
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2010-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Post-Traumatic Stress Disorder (PTSD) and Seroquel
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069348', 'term': 'Quetiapine Fumarate'}], 'ancestors': [{'id': 'D003987', 'term': 'Dibenzothiazepines'}, {'id': 'D013841', 'term': 'Thiazepines'}, {'id': 'D013846', 'term': 'Thiepins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ielman@challiance.org', 'phone': '(617) 665-1000', 'title': 'Igor Elman', 'organization': 'Cambridge Health Alliance'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 years', 'eventGroups': [{'id': 'EG000', 'title': 'Seroquel', 'description': 'This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD\n\nSeroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seroquel', 'description': 'This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD\n\nSeroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '18.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': "We will compare patients' symptomatology at baseline vs. at 8 week timepoint\n\nSpecify Full Scale Name and Construct (i.e., indicate what the scale measures if not clear from name): Clinician-Administered PTSD Scale (CAPS)\n\nInclude all scale ranges (i.e., minimum and maximum scores) required to interpret any values in the data table: 0-136\n\nFor each scale range provided, specify which values are considered to be a better or worse outcome: 0-best, 136 worst\n\nIf subscales are combined to compute a total score, consider indicating how subscales are combined (summed, averaged, etc.): summed", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'It was predicted that patients will show a change in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Seroquel', 'description': 'This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD\n\nSeroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Seroquel', 'description': 'This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD\n\nSeroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.3', 'spread': '8.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-18', 'studyFirstSubmitDate': '2010-02-08', 'resultsFirstSubmitDate': '2017-03-03', 'studyFirstSubmitQcDate': '2010-02-08', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-18', 'studyFirstPostDateStruct': {'date': '2010-02-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint.', 'timeFrame': '8 weeks', 'description': "We will compare patients' symptomatology at baseline vs. at 8 week timepoint\n\nSpecify Full Scale Name and Construct (i.e., indicate what the scale measures if not clear from name): Clinician-Administered PTSD Scale (CAPS)\n\nInclude all scale ranges (i.e., minimum and maximum scores) required to interpret any values in the data table: 0-136\n\nFor each scale range provided, specify which values are considered to be a better or worse outcome: 0-best, 136 worst\n\nIf subscales are combined to compute a total score, consider indicating how subscales are combined (summed, averaged, etc.): summed"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Post-traumatic Stress Disorder', 'PTSD', 'Seroquel', 'fMRI'], 'conditions': ['Post-Traumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'This 8 weeks study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD.', 'detailedDescription': 'An initial telephone interview will be conducted to determine if potential subjects meet the basic study requirements. If no obvious counterindications are present, subjects will be scheduled for a screening visit. After briefing the subjects on the reasons for the research, they will be given an opportunity to read the Informed Consent Form, approved by the Cambridge Health Alliance Institutional ReviewBoard, and to ask questions prior to signing it. Subjects will be given a copy of the signed Consent Form. Each subject will complete a standardized interview schedule designed to obtain personal and background data along with psychodiagnostic and psychometric evaluations. An open-label treatment will be utilized for all patients. Seroquel tablets will be flexibly dosed and begun at a target dose of 25 mg per day and taken over an 8 week period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of written informed consent\n* Fluency in English\n* A diagnosis of PTSD\n* No pregnancy\n* Right-handedness\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Any cognitive impairment that precludes informed consent\n* Known intolerance or lack of response to Seroquel\n* Previous enrollment or randomization of treatment in the present study\n* Participation in another drug trial within 4 weeks prior enrollment into this study\n* Patients with Diabetes Mellitus\n* History of allergic reaction or hypersensitivity to Seroquel\n* Contraindications to magnetic resonance imaging\n* Treatment with an effective medication for PTSD'}, 'identificationModule': {'nctId': 'NCT01066156', 'briefTitle': 'Post-Traumatic Stress Disorder (PTSD) and Seroquel', 'organization': {'class': 'OTHER', 'fullName': 'Cambridge Health Alliance'}, 'officialTitle': 'Functional Reciprocity Between Heightened Stress Reactivity and Emotional Numbing in PTSD: Novel Predictors of Pharmacotherapeutic Outcomes', 'orgStudyIdInfo': {'id': '2009-P-001664'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Seroquel', 'description': 'This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD', 'interventionNames': ['Drug: Seroquel']}], 'interventions': [{'name': 'Seroquel', 'type': 'DRUG', 'otherNames': ['quetiapine'], 'description': 'This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD', 'armGroupLabels': ['Seroquel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02143', 'city': 'Somerville', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Central Street Health Center', 'geoPoint': {'lat': 42.3876, 'lon': -71.0995}}], 'overallOfficials': [{'name': 'Igor Elman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cambridge Health Alliance', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Igor Elman', 'investigatorAffiliation': 'Cambridge Health Alliance'}}}}