NCT00292370

Quetiapine Augmentation for Treatment-resistant PTSD

A Placebo-controlled Trial of Adjunctive Quetiapine for Refractory PTSD

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Combat Disorders
• Stress Disorders, Post-Traumatic

Interventions

Type	Name	Description
DRUG	Open Label (OL) Paroxetine	Open-label Paroxetine
DRUG	Placebo	Double-blind placebo taken with OL paroxetine
DRUG	Quetiapine	Double-blind quetiapine taken with OL paroxetine

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-12-01
• Completion: 2009-05-01
• First posted: 2006-02-15
• Last updated: 2019-10-16
• Results posted: 2014-07-01

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study