Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial

August 18, 2015 updated by: Barbara O. Rothbaum, PhD, Emory University

Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD

The purpose of this study is to determine whether the administration of risperidone is effective in the treatment of selective serotonin reuptake inhibitor (SSRI)-resistant post-traumatic stress disorder (PTSD) in civilians.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Individuals with PTSD often experience anxiety attacks, nightmares, or repeated unwanted memories after experiencing or witnessing life-threatening events, such as serious accidents or natural disasters, or traumatic events such as physical or sexual abuse.

Risperidone has been approved by the Food and Drug Administration for the treatment of psychotic disorders and has been found helpful for PTSD and depression, but is still considered investigational for the purposes of this study.

All qualified participants will be started on sertraline (Zoloft) for eight weeks. Patients who are still symptomatic at the end of this phase, will be invited to join the second portion of the study where they will be randomly assigned to receive risperidone or placebo (sugar pill) in addition to the sertraline. Participants will be monitored regularly for medication effects, adverse events, and PTSD symptoms.

Study Type

Interventional

Enrollment

65

Phase

  • Phase 2
  • Phase 1

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 School of Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center South
    • South Carolina
      • Charleston, South Carolina, United States
        • 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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meets criteria for DSM-IV PTSD for a minimum of one month duration
  • Clinician-Administered PTSD Scale (CAPS) score > or = to 50
  • Able to read and complete questionnaires and interviews
  • Negative urine drug screen

Exclusion Criteria:

  • Pregnant or nursing
  • Primary psychotic disorder; psychotic disorder; or cognitive disorder.
  • Prominent suicidal or homicidal ideation
  • Alcohol or substance dependence within 3 months of starting study
  • Primary anxiety disorder or bipolar disorder
  • Patients currently being treated with antipsychotic medication
  • Patients in active psychotherapy aimed at PTSD
  • Combat-related PTSD

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
Remission of symptoms after 16 weeks

Collaborators and Investigators

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

Sponsor

Emory University

Collaborators

Janssen, LP

Investigators

  • Principal Investigator: Barbara O Rothbaum, PhD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

August 22, 2005

First Submitted That Met QC Criteria

August 23, 2005

First Posted (Estimate)

August 24, 2005

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0184-2004
  • RIS-EMR-4005 (Other Identifier: Other)

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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