Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD)

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

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2007-12-31

Brief Summary

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The purpose of the study is to determine if quetiapine is effective in the treatment of PTSD.

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Detailed Description

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Objective: To assess the impact of quetiapine on core PTSD symptoms and associated psychiatric comorbidity including depressive and positive and negative psychotic symptoms.

Research Design: 12-week, double-blind, placebo-controlled, randomized, fixed-flexible dose trial of quetiapine monotherapy.

Intervention: Eligible patients will be randomized to receive quetiapine starting at 25 mg daily or matching placebo. Dose adjustments (to a minimum of 50 mg or a maximum of 800 mg), will be made at the investigator's discretion and according to patient's clinical response.

Conditions

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PTSD

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

Quetiapine

Group Type EXPERIMENTAL

Quetiapine

Intervention Type DRUG

Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.

Interventions

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Quetiapine

Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.

Intervention Type DRUG

Placebo

Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female patients 18 years of age or older of any ethnic background meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for PTSD.
* Score of at least 50 on the CAPS-SX at baseline.
* Competent to give informed consent.
* If female, patient should be using a medically approved contraceptive, or not otherwise be of childbearing potential.
* Patients who have not taken medications or herbal remedies for a psychiatric indication within one week prior to the randomized phase.
* Other medications, if any, must have been kept stable for at least one month prior to randomization.

Exclusion Criteria

* History of sensitivity to quetiapine
* Use of antipsychotics, antidepressants, or benzodiazepines (except for short-term use during study as specified in Concomitant Medications section) within one week prior to randomization and throughout the study period.
* Medical conditions that may prevent safe administration of quetiapine including clinically significant hepatic, cardiac, or pulmonary disease.
* Medical disorders that may cause or exacerbate anxiety symptoms.
* Alcohol or drug abuse or dependence within one month of study entry as defined by DSM-IV criteria.
* Schizophrenia, schizoaffective disorder, or bipolar disorder.
* Suicidal or homicidal ideation or other clinically significant dangerousness
* Currently seeking compensation or increase in compensation for the effects of the trauma.
* Initiation or change in psychotherapy within 3 months of randomization.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No