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

Post-Traumatic Stress Disorder Clinical Trial

Official title:

A Multicentre, Parallel Group, Randomised, Double Blind, Placebo Controlled Study of the Use of Quetiapine as an Add on Therapy in the Treatment of Post Traumatic Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00306540
• Other study ID #: AU-SEA-0006
• Secondary ID: D1449L00005
• Status: Completed
• Phase: Phase 3
• First received: March 22, 2006
• Last updated: December 8, 2010
• Start date: December 2004
• Est. completion date: August 2008

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Quetiapine Fumarate
oral flexible dose
• quetiapine fumarate placebo
oral 0 mg

Locations

Country	Name	City	State
Australia	Research Site	Adelaide	South Australia
Australia	Research Site	Brisbane	Queensland
Australia	Research Site	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Administered PTSD Scale (CAPS2)
Secondary	Hamilton Depression Scale (HAM-D)
Secondary	Hamilton Anxiety Scale (HAM-A)
Secondary	Posttraumatic Stress Disorder Checklist (PCL)
Secondary	Clinical Global Impressions (CGI)