Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD)

Ralph H. Johnson VA Medical Center

Status and phase

Completed

Phase 4

Conditions

PTSD

Treatments

Drug: Quetiapine

Drug: Placebo

Study type

Interventional

Funder types

Other U.S. Federal agency

Industry

Identifiers

NCT00237393

0058

HR-10762

Details and patient eligibility

About

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

Full 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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.