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

NCT ID: NCT00306540

Last Updated: 2010-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post-Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Placebo Seroquel + existing therapy

Group Type ACTIVE_COMPARATOR

quetiapine fumarate placebo

Intervention Type DRUG

oral 0 mg

2

Seroquel + existing therapy

Group Type EXPERIMENTAL

Quetiapine Fumarate

Intervention Type DRUG

oral flexible dose

Interventions

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Quetiapine Fumarate

oral flexible dose

Intervention Type DRUG

quetiapine fumarate placebo

oral 0 mg

Intervention Type DRUG

Other Intervention Names

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Seroquel

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Australia Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Brisbane, Queensland, Australia

Site Status

Research Site

Adelaide, South Australia, Australia

Site Status

Research Site

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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D1449L00005

Identifier Type: -

Identifier Source: secondary_id

AU-SEA-0006

Identifier Type: -

Identifier Source: org_study_id