Risperidone Augmentation for 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: NCT00215241
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 22, 2014
Janssen Pharmaceuticals
Information provided by:
Duke University

September 20, 2005
September 22, 2005
September 22, 2014
April 2004
Not Provided
Clinician Administered PTSD Scale (CAPS)
Same as current
Complete list of historical versions of study NCT00215241 on Archive Site
  • 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)
Same as current
Not Provided
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Risperidone Augmentation for PTSD
Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD
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.
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.
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Post-Traumatic Stress Disorder
Drug: sertraline and risperidone
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2006
Not Provided

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
5816-05-4R1 ( Other Identifier: Duke legacy protocol ID )
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Duke University
Janssen Pharmaceuticals
Principal Investigator: Jonathan Davidson, M.D. Duke University
Principal Investigator: Barbara Rothbaum, Ph.D. Emory University
Duke University
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP