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Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD)

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Ralph H. Johnson VA Medical Center
ClinicalTrials.gov Identifier:
NCT00237393
First received: October 11, 2005
Last updated: February 20, 2008
Last verified: October 2005
History of Changes
  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 4

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

Resource links provided by NLM:

U.S. FDA Resources

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
Experimental: 1
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.
Placebo Comparator: 2 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

No publications provided

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

Keywords provided by Ralph H. Johnson VA Medical Center:
PTSD
Posttraumatic stress disorder
Treatment
Quetiapine

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 23, 2013