Quetiapine Augmentation for Treatment-resistant PTSD

Completed · Phase 4 · Has a placebo group

Conditions studied: Combat Disorders, Stress Disorders, Post-Traumatic

In brief

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.

Key facts

Study ID

NCT00292370

Run by

VA Office of Research and Development

People needed

124

Starts

2006-01-01

Expected to finish

2009-05-01

Last updated by the study team

2019-10-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Birmingham VA Medical Center — Birmingham, Alabama, United States
• Tuscaloosa VAMC — Tuscaloosa, Alabama, United States
• Ralph H. Johnson — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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