Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD)

Phase 4

Completed

• Conditions: PTSD
• Interventions: Drug: Placebo; Drug: Quetiapine

• Registration Number: NCT00237393
• Lead Sponsor: Ralph H. Johnson VA Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2003-08
• Status Verified: 2005-10
• Study First Submitted: 2005-10-11
• Study First Submitted QC: 2005-10-11
• Study First Posted: 2005-10-12
• Study Completion: 2007-12
• Last Update Submitted: 2008-02-20
• Last Update Posted: 2008-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Quetiapine	Quetiapine

Primary Outcome Measures

Name	Time	Method
Global scores on Clinician Administered PTSD Scale - One Week Symptom Version (CAPS-SX) at week 12

Secondary Outcome Measures

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

Trial Locations

Locations (2)

NM VA Healthcare System; 🇺🇸 Albuquerque, New Mexico, United States

Ralph H. Johnson VAMC; 🇺🇸 Charleston, South Carolina, United States