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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00306540
First received: March 22, 2006
Last updated: December 8, 2010
Last verified: December 2010

March 22, 2006
December 8, 2010
December 2004
September 2007   (final data collection date for primary outcome measure)
Clinical Administered PTSD Scale (CAPS2)
Same as current
Complete list of historical versions of study NCT00306540 on ClinicalTrials.gov Archive Site
  • Hamilton Depression Scale (HAM-D)
  • Hamilton Anxiety Scale (HAM-A)
  • Posttraumatic Stress Disorder Checklist (PCL)
  • Clinical Global Impressions (CGI)
Same as current
Not Provided
Not Provided
 
Use of Quetiapine as an Add on Therapy in the Treatment of Post Traumatic Stress Disorder
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Post-Traumatic Stress Disorder
  • Drug: Quetiapine Fumarate
    oral flexible dose
    Other Name: Seroquel
  • Drug: quetiapine fumarate placebo
    oral 0 mg
  • Active Comparator: 1
    Placebo Seroquel + existing therapy
    Intervention: Drug: quetiapine fumarate placebo
  • Experimental: 2
    Seroquel + existing therapy
    Intervention: Drug: Quetiapine Fumarate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
August 2008
September 2007   (final data collection date for primary outcome measure)

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)
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00306540
AU-SEA-0006, D1449L00005
No
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca Australia Medical Director, MD AstraZeneca
AstraZeneca
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP