Risperidone Augmentation for PTSD
Information source: Duke University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-Traumatic Stress Disorder
Intervention: sertraline and risperidone (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Duke University Official(s) and/or principal investigator(s):
Jonathan Davidson, M.D., Principal Investigator, Affiliation: Duke University
Barbara Rothbaum, Ph.D., Principal Investigator, Affiliation: Emory University
Summary
The purpose of this study is to (1) compare the response of civilians with Posttraumatic
Stress Disorder(PTSD) currently receiving sertraline without an optimal response to
risperidone augmentation vs. placebo, and (2) to evaluate the tolerability of risperidone
augmentation, and (3) to identifiy predictors of response to risperidone augmentation. the
hypothesis is that risperidone augmentation of sertraline treatment of PTSD is safe and
effective.
Clinical Details
Official title: Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Clinician Administered PTSD Scale (CAPS)
Secondary outcome: Davidson Trauma Scale (DTS)Beck Depression Inventory Quality of Life/Q-LES-Q Connor-Davidson Resilience Scale Clinical Global Improvement Scale (CGI-I) Positive and Negative Symptoms Scale (PANSS)
Detailed description:
This is a multi-center, two-phase study to evaluate the efficacy and safety of risperidone
augmentation to sertraline treatment of Post-Traumatic Stress Disorder (PTSD). In the first
phase, all patients will be assigned to take open label sertraline for 8 weeks (up to 200
mg/d). Those who have not achieved a significant decrease in their PTSD symptoms by week 8
will be entered into the second phase. In the second phase, patients will continue with the
sertraline, but will then be randomly given either risperidone (up to 3 mg/d) or matching
placebo in double-blind fashion.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Signed consent prior to any study procedures being done
- Male or female outpatients between 18-65 years of age
- Trauma experienced meets trauma defined by DSM
- Meets criteria for DSM-IV PTSD as a result of civilian trauma
- CAPS Score of greater than or equal to 50 at screening and baseline
- Able to swallow whole capsules
- Fluency in both written and spoken English
- Negative urine drug screen at screening visit
- If female of childbearing potential, must have negative serum pregnancy test at
screening visit and must agree to use a medically accepted means of contraception
throughout the study and for 30 days after completion of the study
- To be include in Phase 2, must complete Phase I and must have less than 70% reduction
from baseline on the CAPS
Exclusion Criteria:
- Pregnant women or those likely to become pregnant, or nursing mothers
- Medical instability (clinically significant hepatic, cardiac, or pulmonary disease,
HIV, uncontrolled hypertension, diabetes or thyroid conditions, seizure disorders,
clinically significant laboratory abnormalities at screen
- Primary psychotic disorder, or history of schizophrenia, other psychotic disorder,
bipolar disorder, or cognitive disorder
- Those considered a risk for suicidal or homicidal behavior (the clinician will
immediately, upon assessing a risk for suicidal or homicidal behavior, refer the
patient for further evaluation and probable hospitalization)
- Hypersensitivity or other contraindication to sertraline or risperidone
- Meeting DSM-IV criteria for drug or alcohol dependence within 3 months of study entry
- Those who are still experiencing an ongoing traumatic stressor (domestic
violence/elder abuse) who will need to focus on safety (the clinician will make
referrals as appropriate)
- DSM-IV primary diagnosis of any other anxiety disorder or major depressive disorder
- Current use of antipsychotic, or other psychotropic medications, or supplements with
known psychotropic effects
- Current involvement in litigation related to PTSD
- Current psychotherapy aimed at treating PTSD
- PTSD as a result of combat-related trauma
- Previous failure to respond to sertraline-risperidone combination at therapeutic dose
Locations and Contacts
Emory University Medical Center, Atlanta, Georgia 30322, United States
Medical University of South Carolina, Charleston, South Carolina 29425, United States
Additional Information
Starting date: April 2004
Ending date: July 2006
Last updated: December 18, 2006
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