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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00306540
Recruitment Status : Completed
First Posted : March 24, 2006
Last Update Posted : December 9, 2010
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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.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Drug: Quetiapine Fumarate Drug: quetiapine fumarate placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : December 2004
Actual Primary Completion Date : September 2007
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Placebo Seroquel + existing therapy
Drug: quetiapine fumarate placebo
oral 0 mg
Experimental: 2
Seroquel + existing therapy
Drug: Quetiapine Fumarate
oral flexible dose
Other Name: Seroquel

Primary Outcome Measures :
  1. Clinical Administered PTSD Scale (CAPS2)

Secondary Outcome Measures :
  1. Hamilton Depression Scale (HAM-D)
  2. Hamilton Anxiety Scale (HAM-A)
  3. Posttraumatic Stress Disorder Checklist (PCL)
  4. Clinical Global Impressions (CGI)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00306540

Australia, Queensland
Research Site
Brisbane, Queensland, Australia
Australia, South Australia
Research Site
Adelaide, South Australia, Australia
Australia, Victoria
Research Site
Melbourne, Victoria, Australia
Sponsors and Collaborators
Study Director: AstraZeneca Australia Medical Director, MD AstraZeneca Identifier: NCT00306540     History of Changes
Other Study ID Numbers: AU-SEA-0006
First Posted: March 24, 2006    Key Record Dates
Last Update Posted: December 9, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs