Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial

This study has been completed.
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Barbara O. Rothbaum, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00133822
First received: August 22, 2005
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Post-Traumatic Stress Disorders
Drug: Sertraline and Risperidone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Remission of symptoms after 16 weeks

Estimated Enrollment: 65
Study Start Date: April 2004
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133822

Locations
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
Investigators
Principal Investigator: Barbara O Rothbaum, PHD Emory University
  More Information

No publications provided by Emory University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barbara O. Rothbaum, PhD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00133822     History of Changes
Other Study ID Numbers: 0184-2004, RIS-EMR-4005
Study First Received: August 22, 2005
Last Updated: November 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Post-Traumatic Stress Disorder
Sertraline
Risperidone

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Anxiety Disorders
Mental Disorders
Risperidone
Sertraline
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014