Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD) (PTSD)
February 20, 2008 updated by: Ralph H. Johnson VA Medical Center
A Randomized, Placebo-Controlled Trial of Quetiapine (Seroquel) Monotherapy in the Treatment of PTSD
The purpose of the study is to determine if quetiapine is effective in the treatment of PTSD.
Study Overview
Detailed Description
Objective: To assess the impact of quetiapine on core PTSD symptoms and associated psychiatric comorbidity including depressive and positive and negative psychotic symptoms.
Research Design: 12-week, double-blind, placebo-controlled, randomized, fixed-flexible dose trial of quetiapine monotherapy.
Intervention: 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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Mexico
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Albuquerque, New Mexico, United States, 87108
- NM VA Healthcare System
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South Carolina
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Charleston, South Carolina, United States, 29401
- Ralph H. Johnson VAMC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- Score of at least 50 on the CAPS-SX at baseline.
- Competent to give informed consent.
- If female, patient should be using a medically approved contraceptive, or not otherwise be of childbearing potential.
- Patients who have not taken medications or herbal remedies for a psychiatric indication within one week prior to the randomized phase.
- Other medications, if any, must have been kept stable for at least one month prior to randomization.
Exclusion Criteria:
- History of sensitivity to quetiapine
- 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.
- Medical conditions that may prevent safe administration of quetiapine including clinically significant hepatic, cardiac, or pulmonary disease.
- Medical disorders that may cause or exacerbate anxiety symptoms.
- Alcohol or drug abuse or dependence within one month of study entry as defined by DSM-IV criteria.
- Schizophrenia, schizoaffective disorder, or bipolar disorder.
- Suicidal or homicidal ideation or other clinically significant dangerousness
- Currently seeking compensation or increase in compensation for the effects of the trauma.
- Initiation or change in psychotherapy within 3 months of randomization.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: 2
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Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.
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Experimental: 1
Quetiapine
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Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Global scores on Clinician Administered PTSD Scale - One Week Symptom Version (CAPS-SX) at week 12
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Secondary Outcome Measures
Outcome Measure |
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Hamilton Depression Rating Scale (HAMD)
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Davidson Trauma Scale (DTS)
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Week 12 scores on Positive and Negative Syndrome Scale (PANSS)
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Hamilton Rating Scale of Anxiety (HAMA)
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Clinical Global Impression Severity Scale (CGI-S)
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Clinical Global Impression Improvement Scale (CGI-I)
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Pittsburgh Sleep Quality Inventory/Pittsburgh Sleep Quality Inventory Addendum (PSQI/PSQI-A)
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Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)
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SDS
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Arizona Sexual Experience Scale (ASEX)
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AIMS
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BAS
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SAS
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mark B Hamner, MD, Ralph H. Johnson VAMC/Medical University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2003
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
October 11, 2005
First Submitted That Met QC Criteria
October 11, 2005
First Posted (Estimate)
October 12, 2005
Study Record Updates
Last Update Posted (Estimate)
February 21, 2008
Last Update Submitted That Met QC Criteria
February 20, 2008
Last Verified
October 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0058
- HR-10762
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.