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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Post-Traumatic Stress Disorder

Treatments: Drug: quetiapine fumarate placebo; Drug: Quetiapine Fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00306540

AU-SEA-0006

D1449L00005

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups

1

Active Comparator group

Description:

Placebo Seroquel + existing therapy

Treatment:

Drug: quetiapine fumarate placebo

2

Experimental group

Description:

Seroquel + existing therapy

Treatment:

Drug: Quetiapine Fumarate