Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD)

PTSD Clinical Trial

— PTSD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237393
• Other study ID #: 0058
• Secondary ID: HR-10762
• Status: Completed
• Phase: Phase 4
• First received: October 11, 2005
• Last updated: February 20, 2008
• Start date: August 2003
• Est. completion date: December 2007

Study information

• Verified date: October 2005
• Source: Ralph H. Johnson VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Intervention

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

Locations

Country	Name	City	State
United States	NM VA Healthcare System	Albuquerque	New Mexico
United States	Ralph H. Johnson VAMC	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Ralph H. Johnson VA Medical Center	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global scores on Clinician Administered PTSD Scale - One Week Symptom Version (CAPS-SX) at week 12
Secondary	Week 12 scores on Positive and Negative Syndrome Scale (PANSS)
Secondary	Hamilton Depression Rating Scale (HAMD)
Secondary	Hamilton Rating Scale of Anxiety (HAMA)
Secondary	Clinical Global Impression Severity Scale (CGI-S)
Secondary	Clinical Global Impression Improvement Scale (CGI-I)
Secondary	Davidson Trauma Scale (DTS)
Secondary	Pittsburgh Sleep Quality Inventory/Pittsburgh Sleep Quality Inventory Addendum (PSQI/PSQI-A)
Secondary	Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)
Secondary	SDS
Secondary	Arizona Sexual Experience Scale (ASEX)
Secondary	AIMS
Secondary	BAS
Secondary	SAS