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Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD) (PTSD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00237393
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : February 21, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
PTSD Drug: Quetiapine Drug: Placebo Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled Trial of Quetiapine (Seroquel) Monotherapy in the Treatment of PTSD
Study Start Date : August 2003
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
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.

Primary Outcome Measures :
  1. Global scores on Clinician Administered PTSD Scale - One Week Symptom Version (CAPS-SX) at week 12

Secondary Outcome Measures :
  1. Week 12 scores on Positive and Negative Syndrome Scale (PANSS)
  2. Hamilton Depression Rating Scale (HAMD)
  3. Hamilton Rating Scale of Anxiety (HAMA)
  4. Clinical Global Impression Severity Scale (CGI-S)
  5. Clinical Global Impression Improvement Scale (CGI-I)
  6. Davidson Trauma Scale (DTS)
  7. Pittsburgh Sleep Quality Inventory/Pittsburgh Sleep Quality Inventory Addendum (PSQI/PSQI-A)
  8. Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)
  9. SDS
  10. Arizona Sexual Experience Scale (ASEX)
  11. AIMS
  12. BAS
  13. SAS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00237393

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
Principal Investigator: Mark B Hamner, MD Ralph H. Johnson VAMC/Medical University of South Carolina

Responsible Party: Mark B. Hamner, MD, Ralph H. Johnson VA Medical Center Identifier: NCT00237393     History of Changes
Other Study ID Numbers: 0058
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: February 21, 2008
Last Verified: October 2005

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

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs