Status:
COMPLETED
Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD)
Lead Sponsor:
Ralph H. Johnson VA Medical Center
Collaborating Sponsors:
AstraZeneca
Conditions:
PTSD
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to determine if quetiapine is effective in the treatment of PTSD.
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,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00237393
Start Date
August 1 2003
End Date
December 1 2007
Last Update
February 21 2008
Active Locations (2)
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1
NM VA Healthcare System
Albuquerque, New Mexico, United States, 87108
2
Ralph H. Johnson VAMC
Charleston, South Carolina, United States, 29401