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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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00306540
First received: March 22, 2006
Last updated: December 8, 2010
Last verified: December 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00306540     History of Changes
Other Study ID Numbers: AU-SEA-0006, D1449L00005
Study First Received: March 22, 2006
Last Updated: December 8, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013