Risperidone Augmentation for PTSD

September 18, 2014 updated by: Duke University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinician Administered PTSD Scale (CAPS)

Secondary Outcome Measures

Outcome Measure
Davidson Trauma Scale (DTS)
Beck Depression Inventory
Connor-Davidson Resilience Scale
Quality of Life/Q-LES-Q
Clinical Global Improvement Scale (CGI-I)
Positive and Negative Symptoms Scale (PANSS)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Janssen Pharmaceuticals

Investigators

  • Principal Investigator: Jonathan Davidson, M.D., Duke University
  • Principal Investigator: Barbara Rothbaum, Ph.D., Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion

July 1, 2006

Study Registration Dates

First Submitted

September 20, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

September 22, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5816
  • 5816-05-4R1 (Other Identifier: Duke legacy protocol ID)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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