Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD)

Sponsor

Ralph H. Johnson VA Medical Center (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00237393

Collaborator

AstraZeneca (Industry)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
PTSD	Drug: Quetiapine Drug: Placebo	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Placebo-Controlled Trial of Quetiapine (Seroquel) Monotherapy in the Treatment of PTSD

Study Start Date :

Aug 1, 2003

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Quetiapine	Drug: Quetiapine Dosage initiated at 25 mg HS with gradual titration to target dose of 400 mg HS, up to maximum of 800 mg HS.
Placebo Comparator: 2	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.

Arm

Intervention/Treatment

Experimental: 1

Quetiapine

Drug: Quetiapine

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

Placebo Comparator: 2

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.

Outcome Measures

Primary Outcome Measures

Global scores on Clinician Administered PTSD Scale - One Week Symptom Version (CAPS-SX) at week 12 []

Secondary Outcome Measures

Week 12 scores on Positive and Negative Syndrome Scale (PANSS) []
Hamilton Depression Rating Scale (HAMD) []
Hamilton Rating Scale of Anxiety (HAMA) []
Clinical Global Impression Severity Scale (CGI-S) []
Clinical Global Impression Improvement Scale (CGI-I) []
Davidson Trauma Scale (DTS) []
Pittsburgh Sleep Quality Inventory/Pittsburgh Sleep Quality Inventory Addendum (PSQI/PSQI-A) []
Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) []
SDS []
Arizona Sexual Experience Scale (ASEX) []
AIMS []
BAS []
SAS []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.