Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD) - Full Text View

Sponsors and Collaborators:	Ralph H. Johnson VA Medical Center AstraZeneca
Information provided by:	Ralph H. Johnson VA Medical Center
ClinicalTrials.gov Identifier:	NCT00237393

Purpose

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

Condition	Intervention	Phase
PTSD	Drug: Quetiapine Drug: Placebo	Phase IV

MedlinePlus related topics: Anxiety Post-Traumatic Stress Disorder

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Placebo-Controlled Trial of Quetiapine (Seroquel) Monotherapy in the Treatment of PTSD

Further study details as provided by Ralph H. Johnson VA Medical Center:

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

Enrollment:	80
Study Start Date:	August 2003
Study Completion Date:	December 2007

Arms	Assigned Interventions
1: Experimental 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.
2: Placebo Comparator	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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237393

Locations

United States, New Mexico
NM VA Healthcare System
Albuquerque, New Mexico, United States, 87108
United States, South Carolina
Ralph H. Johnson VAMC
Charleston, South Carolina, United States, 29401

Sponsors and Collaborators

Ralph H. Johnson VA Medical Center

AstraZeneca

Investigators

Principal Investigator:

Mark B Hamner, MD

Ralph H. Johnson VAMC/Medical University of South Carolina

More Information

Responsible Party:	Ralph H. Johnson VA Medical Center ( Mark B. Hamner, MD )
Study ID Numbers:	0058, HR-10762
Study First Received:	October 11, 2005
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00237393
Health Authority:	United States: Federal Government

Keywords provided by Ralph H. Johnson VA Medical Center:

PTSD
Posttraumatic stress disorder
Treatment
Quetiapine

Study placed in the following topic categories:

Quetiapine
Anxiety Disorders
Mental Disorders

Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009