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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

Brief 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.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Drug: sertraline and risperidone Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD
Study Start Date : April 2004
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Clinician Administered PTSD Scale (CAPS)

Secondary Outcome Measures :
  1. Davidson Trauma Scale (DTS)
  2. Beck Depression Inventory
  3. Quality of Life/Q-LES-Q
  4. Connor-Davidson Resilience Scale
  5. Clinical Global Improvement Scale (CGI-I)
  6. Positive and Negative Symptoms Scale (PANSS)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00215241

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United States, Georgia
Emory University Medical Center
Atlanta, Georgia, United States, 30322
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Duke University
Janssen Pharmaceuticals
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Principal Investigator: Jonathan Davidson, M.D. Duke University
Principal Investigator: Barbara Rothbaum, Ph.D. Emory University
Layout table for additonal information Identifier: NCT00215241    
Other Study ID Numbers: 5816
5816-05-4R1 ( Other Identifier: Duke legacy protocol ID )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2014
Last Verified: June 2006
Keywords provided by Duke University:
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators