Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT00237393
Status:
COMPLETED
Last Update Posted:
2008-02-21
First Post:
2005-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-10', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-20', 'studyFirstSubmitDate': '2005-10-11', 'studyFirstSubmitQcDate': '2005-10-11', 'lastUpdatePostDateStruct': {'date': '2008-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global scores on Clinician Administered PTSD Scale - One Week Symptom Version (CAPS-SX) at week 12'}], 'secondaryOutcomes': [{'measure': 'Week 12 scores on Positive and Negative Syndrome Scale (PANSS)'}, {'measure': 'Hamilton Depression Rating Scale (HAMD)'}, {'measure': 'Hamilton Rating Scale of Anxiety (HAMA)'}, {'measure': 'Clinical Global Impression Severity Scale (CGI-S)'}, {'measure': 'Clinical Global Impression Improvement Scale (CGI-I)'}, {'measure': 'Davidson Trauma Scale (DTS)'}, {'measure': 'Pittsburgh Sleep Quality Inventory/Pittsburgh Sleep Quality Inventory Addendum (PSQI/PSQI-A)'}, {'measure': 'Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)'}, {'measure': 'SDS'}, {'measure': 'Arizona Sexual Experience Scale (ASEX)'}, {'measure': 'AIMS'}, {'measure': 'BAS'}, {'measure': 'SAS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PTSD', 'Posttraumatic stress disorder', 'Treatment', 'Quetiapine'], 'conditions': ['PTSD']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if quetiapine is effective in the treatment of PTSD.', 'detailedDescription': "Objective: To assess the impact of quetiapine on core PTSD symptoms and associated psychiatric comorbidity including depressive and positive and negative psychotic symptoms.\n\nResearch Design: 12-week, double-blind, placebo-controlled, randomized, fixed-flexible dose trial of quetiapine monotherapy.\n\nIntervention: Eligible patients will be randomized to receive quetiapine starting at 25 mg daily or matching placebo. Dose adjustments (to a minimum of 50 mg or a maximum of 800 mg), will be made at the investigator's discretion and according to patient's clinical response."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients 18 years of age or older of any ethnic background meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for PTSD.\n* Score of at least 50 on the CAPS-SX at baseline.\n* Competent to give informed consent.\n* If female, patient should be using a medically approved contraceptive, or not otherwise be of childbearing potential.\n* Patients who have not taken medications or herbal remedies for a psychiatric indication within one week prior to the randomized phase.\n* Other medications, if any, must have been kept stable for at least one month prior to randomization.\n\nExclusion Criteria:\n\n* History of sensitivity to quetiapine\n* Use of antipsychotics, antidepressants, or benzodiazepines (except for short-term use during study as specified in Concomitant Medications section) within one week prior to randomization and throughout the study period.\n* Medical conditions that may prevent safe administration of quetiapine including clinically significant hepatic, cardiac, or pulmonary disease.\n* Medical disorders that may cause or exacerbate anxiety symptoms.\n* Alcohol or drug abuse or dependence within one month of study entry as defined by DSM-IV criteria.\n* Schizophrenia, schizoaffective disorder, or bipolar disorder.\n* Suicidal or homicidal ideation or other clinically significant dangerousness\n* Currently seeking compensation or increase in compensation for the effects of the trauma.\n* Initiation or change in psychotherapy within 3 months of randomization.'}, 'identificationModule': {'nctId': 'NCT00237393', 'acronym': 'PTSD', 'briefTitle': 'Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD)', 'organization': {'class': 'FED', 'fullName': 'Ralph H. Johnson VA Medical Center'}, 'officialTitle': 'A Randomized, Placebo-Controlled Trial of Quetiapine (Seroquel) Monotherapy in the Treatment of PTSD', 'orgStudyIdInfo': {'id': '0058'}, 'secondaryIdInfos': [{'id': 'HR-10762'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Quetiapine', 'interventionNames': ['Drug: Quetiapine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Quetiapine', 'type': 'DRUG', 'description': 'Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87108', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'NM VA Healthcare System', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '29401', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Ralph H. Johnson VAMC', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Mark B Hamner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ralph H. Johnson VAMC/Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ralph H. Johnson VA Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Mark B. Hamner, MD', 'oldOrganization': 'Ralph H. Johnson VA Medical Center'}}}}