Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial - Full Text View

Sponsors and Collaborators:	Emory University Janssen, LP
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00133822

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 I Phase II

MedlinePlus related topics: Post-Traumatic Stress Disorder

Drug Information available for: Sertraline hydrochloride Sertraline Risperidone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD

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
Estimated Study Completion Date:	March 2006

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

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

Publications indexed to this study:

Rothbaum BO, Killeen TK, Davidson JR, Brady KT, Connor KM, Heekin MH. Placebo-controlled trial of risperidone augmentation for selective serotonin reuptake inhibitor-resistant civilian posttraumatic stress disorder. J Clin Psychiatry. 2008 Apr;69(4):520-5.

Study ID Numbers:	RIS-EMR-4005, 184-2004
Study First Received:	August 22, 2005
Last Updated:	December 15, 2006
ClinicalTrials.gov Identifier:	NCT00133822
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

Post-Traumatic Stress Disorder
Sertraline
Risperidone

Study placed in the following topic categories:

Dopamine
Anxiety Disorders
Mental Disorders
Risperidone
Sertraline

Stress Disorders, Post-Traumatic
Stress
Serotonin
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents

Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 14, 2009