Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial

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: NCT00133822
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : August 19, 2015
Janssen, LP
Information provided by (Responsible Party):
Barbara O. Rothbaum, PhD, Emory University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorders Drug: Sertraline and Risperidone Phase 1 Phase 2

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  (Clinical Trial)
Enrollment : 65 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
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Remission of symptoms after 16 weeks

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:   Yes

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

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): NCT00133822

United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, North Carolina
Duke University Medical Center South
Durham, North Carolina, United States, 27710
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States
Sponsors and Collaborators
Emory University
Janssen, LP
Principal Investigator: Barbara O Rothbaum, PHD Emory University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Barbara O. Rothbaum, PhD, Professor, Emory University Identifier: NCT00133822     History of Changes
Other Study ID Numbers: 0184-2004
RIS-EMR-4005 ( Other Identifier: Other )
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015

Keywords provided by Barbara O. Rothbaum, PhD, Emory University:
Post-Traumatic Stress Disorder

Additional relevant MeSH terms:
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