Use of Quetiapine as an Add on Therapy in the Treatment of Post Traumatic Stress Disorder

Phase 3

Completed

• Conditions: Post-Traumatic Stress Disorder
• Interventions: Drug: quetiapine fumarate placebo; Drug: Quetiapine Fumarate

• Registration Number: NCT00306540
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to evaluate how effective quetiapine versus placebo is when added to an existing therapy, in reducing the symptoms of PTSD.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2006-03-22
• Study First Submitted QC: 2006-03-22
• Study First Posted: 2006-03-24
• Primary Completion: 2007-09
• Study Completion: 2008-08
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Hospitalised and non-hospitalised patients / Veteran or Civilian / Have had symptoms of PTSD for a minimum of 12 months prior to giving consent to the study

Exclusion Criteria

• History of psychotic condition / quetiapine or other anti-psychotics not worked previously / Taking prohibited medications (mood stabilizers / substance abuse)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	quetiapine fumarate placebo	Placebo Seroquel + existing therapy
2	Quetiapine Fumarate	Seroquel + existing therapy

Primary Outcome Measures

Name	Time	Method
Clinical Administered PTSD Scale (CAPS2)

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Scale (HAM-D)
Hamilton Anxiety Scale (HAM-A)
Posttraumatic Stress Disorder Checklist (PCL)
Clinical Global Impressions (CGI)

Trial Locations

Locations (1)

Research Site; 🇦🇺 Melbourne, Victoria, Australia