Clinical Trial: Quetiapine Augmentation for Treatment-resistant PTSD

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: VA Office of Research and Development

Current Primary Outcome: Change in Clinician-Administered PTSD Scale for DSM-IV Total Score. [ Time Frame: From baseline (week 8) to endpoint (week 16 or termination) ]

The Clinician-Administered PTSD Scale for DSM-IV (CAPS) is described in the National Center for PTSD Instruction Manual (November 2000) as a semi-structured clinical interview designed to assess the seventeen symptoms for Post Traumatic Stress Disorder (PTSD) outlined in the DSM-IV, along with five associated features. Ratings are made on a 5 point continuum from the lowest frequency or intensity to the highest. Total CAPS score is a summed score that ranges from 0 to 136 where 0 is asymptomatic and higher scores equal more severe PTSD symptomatology. Also, a change in total CAPS score of 15 points was proposed as clinically significant change.


Original Primary Outcome: Total CAPS change score from baseline to endpoint.

Current Secondary Outcome: PANSS,HAMD,CGI,DTS, PSQI,PSQI-A, Dream/Sleep Diary,Q-LES-Q,SDS,ASEX,AIMS, BAS, SAS [ Time Frame: Baseline to endpoint change scores ]

Original Secondary Outcome: Baseline to endpoint change scores in PANSS,HAMD,CGI,DTS, PSQI,PSQI-A, Dream/Sleep Diary,Q-LES-Q,SDS,ASEX,AIMS, BAS, SAS

Information By: VA Office of Research and Development

Dates:
Date Received: February 13, 2006
Date Started: January 2006
Date Completion:
Last Updated: June 27, 2014
Last Verified: June 2014