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Quetiapine Augmentation for Treatment-resistant PTSD

Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Combat Disorders; Stress Disorders, Post-Traumatic

Intervention: Open Label (OL) Paroxetine (Drug); Placebo (Drug); Quetiapine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Department of Veterans Affairs

Official(s) and/or principal investigator(s):
Mark B Hamner, MD BS, Principal Investigator, Affiliation: Ralph H. Johnson VA Medical Center

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.

Clinical Details

Official title: A Placebo-controlled Trial of Adjunctive Quetiapine for Refractory PTSD

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in Clinician-Administered PTSD Scale for DSM-IV Total Score.

Secondary outcome: PANSS,HAMD,CGI,DTS, PSQI,PSQI-A, Dream/Sleep Diary,Q-LES-Q,SDS,ASEX,AIMS, BAS, SAS

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 Phase I, eligible patients will take open-label paroxetine (up to 60 mg daily) for 8 weeks. Patients who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for the second phase. In Phase II, patients will continue taking open-label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) or placebo for 8 weeks in a double-blind fashion.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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.

Locations and Contacts

Birmingham VA Medical Center, Birmingham, Alabama 35233, United States

Tuscaloosa VAMC, Tuscaloosa, Alabama 35404, United States

Ralph H. Johnson, Charleston, South Carolina 29401-5799, United States

Additional Information

Related publications:

Weathers FW, Keane TM, Davidson JR. Clinician-administered PTSD scale: a review of the first ten years of research. Depress Anxiety. 2001;13(3):132-56. Review.

Starting date: January 2006
Last updated: June 27, 2014

Page last updated: August 23, 2015

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