Quetiapine Treatment for Post-Traumatic Stress Disorder (PTSD)
Information source: Ralph H. Johnson VA Medical Center
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: PTSD
Intervention: Quetiapine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Hamner, Mark B., M.D. Official(s) and/or principal investigator(s):
Mark B Hamner, MD, Principal Investigator, Affiliation: Ralph H. Johnson VAMC/Medical University of South Carolina
Overall contact:
Sophie Robert, PharmD, Phone: 843-789-7502, Email: robertso@musc.edu
Summary
The purpose of the study is to determine if quetiapine is effective in the treatment of
PTSD.
Clinical Details
Official title: A Randomized, Placebo-Controlled Trial of Quetiapine (Seroquel) Monotherapy in the Treatment of PTSD
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Global scores on Clinician Administered PTSD Scale - One Week Symptom Version (CAPS-SX) at week 12
Secondary outcome: 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
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Sophie Robert, PharmD, Phone: 843-789-7502, Email: robertso@musc.edu
NM VA Healthcare System, Albuquerque, New Mexico 87108, United States; Recruiting
Lawrence Calais, RN, Phone: 505-265-1711, Ext: 2677, Email: lawrence.calais@med.va.gov
Jose Canive, MD, Principal Investigator
Ralph H. Johnson VAMC, Charleston, South Carolina 29401, United States; Recruiting
Sophie Robert, PharmD, Phone: 843-789-7502, Email: robertso@musc.edu
Deborah Agbor-Tabi, Phone: 843-789-7147, Email: agbortab@musc.edu
Mark B Hamner, MD, Principal Investigator
Additional Information
Starting date: August 2003
Last updated: February 17, 2006
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