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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00306540
First Posted: March 24, 2006
Last Update Posted: December 9, 2010
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.
Information provided by:
AstraZeneca
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
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 ClinicalTrials.gov identifier (NCT number): NCT00306540


Locations
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
AstraZeneca
Investigators
Study Director: AstraZeneca Australia Medical Director, MD AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00306540     History of Changes
Other Study ID Numbers: AU-SEA-0006
D1449L00005
First Submitted: March 22, 2006
First Posted: March 24, 2006
Last Update Posted: December 9, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Disease
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