Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD)

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ralph H. Johnson VA Medical Center
• Collaborator: AstraZeneca
• Treatments: Quetiapine Fumarate

Criteria

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.