Use of Quetiapine as an Add on Therapy in the Treatment of Post Traumatic Stress Disorder - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00306540

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: quietipine fumarate placebo	Phase III

MedlinePlus related topics: Anxiety Post-Traumatic Stress Disorder

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

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
Estimated Study Completion Date:	August 2008

Arms	Assigned Interventions
1: Active Comparator Placebo Seroquel + existing therapy	Drug: quietipine fumarate placebo oral 0 mg
2: Experimental Seroquel + existing therapy	Drug: Quetiapine Fumarate oral flexible dose

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

Contacts

Contact: AstraZeneca Pty Ltd

+61 2 9978 3500

Locations

Australia, Queensland
Research Site	Recruiting
Brisbane, Queensland, Australia
Australia, South Australia
Research Site	Recruiting
Adelaide, South Australia, Australia
Australia, Victoria
Research Site	Recruiting
Melbourne, Victoria, Australia

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Australia Medical Director, MD

AstraZeneca

More Information

Study ID Numbers:	AU-SEA-006
Study First Received:	March 22, 2006
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00306540
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:

Quetiapine
Anxiety Disorders
Mental Disorders

Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Tranquilizing Agents
Pathologic Processes
Disease
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009