Status:
COMPLETED
Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder
Lead Sponsor:
US Department of Veterans Affairs
Collaborating Sponsors:
Janssen, LP
Conditions:
Stress Disorders
Post-Traumatic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this research of 400 participants is to determine whether a drug called risperidone can decrease symptoms of Post-Traumatic Stress Disorder (PTSD). It is a placebo-controlled study, mea...
Detailed Description
Primary Hypothesis: Risperidone will reduce symptoms of PTSD, relative to placebo, in veterans with military service related chronic PTSD who have been partial or non-responders to antidepressant medi...
Eligibility Criteria
Inclusion
- 18 years or older
- Military service related chronic PTSD
- CAPS score \>50
- Participant in VA outpatient PTSD clinic
- History of non-response to two or more antidepressants
Exclusion
- Comorbid Axis I diagnosis requiring antipsychotic medication
- Substance dependence diagnosis (excluding nicotine)
- Hepatic or renal problems
- Incompatible medical diagnosis or medication (i.e., coumadin, insulin)
- Unstable living arrangements
- Assault or suicide gesture within 1 year
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT00099983
Start Date
October 1 2006
End Date
January 1 2011
Last Update
August 22 2014
Active Locations (20)
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1
VA Medical Center, Tuscaloosa
Tuscaloosa, Alabama, United States, 35404
2
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
3
VA Medical Center, San Francisco
San Francisco, California, United States, 94121
4
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073