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OpenTrials
Completed

NCT Number: NCT00306540

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.

Completed

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Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Brisbane, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Quetiapine fumarate

Drug

oral flexible dose

Other names: Seroquel

quetiapine fumarate placebo

Drug

oral 0 mg

Primary outcomes

  1. Clinical Administered PTSD Scale (CAPS2)

Secondary outcomes

  1. Hamilton Depression Scale (HAM-D)

  2. Hamilton Anxiety Scale (HAM-A)

  3. Posttraumatic Stress Disorder Checklist (PCL)

  4. Clinical Global Impressions (CGI)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Mar 24, 2006
Registry last updated
Dec 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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