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

December 8, 2010 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • Seroquel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical Administered PTSD Scale (CAPS2)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (ACTUAL)

September 1, 2007

Study Completion (ACTUAL)

August 1, 2008

Study Registration Dates

First Submitted

March 22, 2006

First Submitted That Met QC Criteria

March 22, 2006

First Posted (ESTIMATE)

March 24, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

December 9, 2010

Last Update Submitted That Met QC Criteria

December 8, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU-SEA-0006
  • D1449L00005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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