Clinical Trial: Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial

This study is currently recruiting patients.
Verified by Emory University August 2005

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

Purpose

The purpose of this study is to determine whether administration of Risperidone is effective in the treatment of SSRI-Resistant Post-Traumatic Stress Disorder in Civilians.
Condition Intervention Phase
Post-Traumatic Stress Disorder
 Drug: Sertraline and Risperidone
Phase I
Phase II

MedlinePlus related topics:  Post-Traumatic Stress Disorder

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: 
Primary Outcomes: Remission of symptoms after 16 weeks
Expected Total Enrollment:  65

Study start: April 2004;  Expected completion: April 2006
Last follow-up: March 2006;  Data entry closure: April 2006

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 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   -   65 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Meets criteria for DSM-IV PTSD for a minimum of one month duration
  • 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, 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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00133822


Georgia
      Emory University School of Medicine, Atlanta,  Georgia,  30322,  United States; Recruiting
Britt Bruce, M.S.  404-778-8277    tarp@emory.edu 
Barbara O Rothbaum, PhD  404-778-8277    tarp@emory.edu 
Barbara O Rothbaum, PhD,  Principal Investigator

North Carolina
      Duke University Medical Center South, Durham,  North Carolina,  27710,  United States; Recruiting
Nabila Danish  919-684-5849    danis002@mc.duke.edu 
Jonathan Davidson, MD
Jonathan Davidson, MD,  Principal Investigator

South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  United States; Recruiting
Virginia Schwartz  843-792-4847    schwartv@musc.edu 
Therese Killeen
Therese Killeen,  Principal Investigator

Study chairs or principal investigators

Barbara O Rothbaum, PHD,  Principal Investigator,  Emory University   

More Information

Study ID Numbers:  RIS-EMR-4005; 184-2004
Last Updated:  August 23, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00133822
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-30

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