Status:
COMPLETED
Quetiapine Augmentation for Treatment-resistant PTSD
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
AstraZeneca
Conditions:
Combat Disorders
Stress Disorders, Post-Traumatic
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the response of veterans with PTSD without an optimal response to paroxetine to quetiapine augmentation versus placebo.
Detailed Description
This is a two-site study designed to evaluate the efficacy and safety of quetiapine augmentation of paroxetine treatment in veterans with PTSD who have failed to respond to paroxetine treatment. In P...
Eligibility Criteria
Inclusion
- Veteran age 18 to 75.
- Competent to give informed consent.
- Meeting DSM-IV criteria for PTSD.
- Minimal CAPS score of 50 at baseline.
- If female of childbearing potential, patient must have a negative pregnancy test and, if sexually active, be using a medically approved contraceptive method.
- Patients who have not taken psychiatric medications within 1 week prior to study entry (except fluoxetine \[5 weeks\])
- monoamine oxidase inhibitors (MAOIs \[4 weeks\])
- depot neuroleptics \[4 weeks\])
- or any investigational drug within 30 days prior to study enrollment.
- To be eligible for Phase II
- patients must be refractory to paroxetine in Phase I, as defined by less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8
- must have PTSD symptoms at least moderate severity on CGI-S
- and must have been compliant with study medicine in Phase I, as defined by taking at least 80% of prescribed doses.
Exclusion
- History of sensitivity to paroxetine or quetiapine.
- Failure to respond to a prior adequate therapeutic trial i.e. minimum of 8 weeks at maximum tolerated dose of paroxetine (up to 60 mg daily) or quetiapine (up to 800 mg daily).
- Women who are
- breast-feeding
- pregnant
- expect to become pregnant during the course of the study
- or are sexually active and are not using a medically acceptable method of birth control.
- Presence of clinically significant hepatic
- cardiovascular
- or other medical conditions that may prevent safe administration of paroxetine or quetiapine
- or any other clinically significant unstable medical conditions.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00292370
Start Date
January 1 2006
End Date
May 1 2009
Last Update
October 16 2019
Active Locations (3)
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1
Birmingham VA Medical Center
Birmingham, Alabama, United States, 35233
2
Tuscaloosa VAMC
Tuscaloosa, Alabama, United States, 35404
3
Ralph H. Johnson
Charleston, South Carolina, United States, 29401-5799