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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: March 22, 2006
Last updated: December 8, 2010
Last verified: December 2010
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 Intervention Phase
Post-Traumatic Stress Disorder Drug: Quetiapine Fumarate Drug: quetiapine fumarate placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Clinical Administered PTSD Scale (CAPS2)

Secondary Outcome Measures:
  • Hamilton Depression Scale (HAM-D)
  • Hamilton Anxiety Scale (HAM-A)
  • Posttraumatic Stress Disorder Checklist (PCL)
  • Clinical Global Impressions (CGI)

Estimated Enrollment: 90
Study Start Date: December 2004
Study Completion Date: August 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information Identifier: NCT00306540     History of Changes
Other Study ID Numbers: AU-SEA-0006
Study First Received: March 22, 2006
Last Updated: December 8, 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 processed this record on September 19, 2017