Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder
- Registration Number
- NCT00099983
- Lead Sponsor
- US Department of Veterans Affairs
- 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, meaning that half of the participants will be assigned to receive a pill that contains no drug. The treatment phase of the study will last for 6 months, during which time participants will continue to receive all their usual treatments in addition to the study treatment and will be asked to complete procedures and assessments (questionnaires, interviews, laboratory tests, physical exams, etc.) related to their PTSD symptoms at various points within the 6-month treatment phase. At the end of the 6-month study, participants will discontinue the study treatment.
- 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 medications.
Secondary Hypothesis: Risperidone is safe and well-tolerated in veterans with military service related chronic PTSD, and patients will comply with its prescription. As a result, patients will show improvement in the secondary consequences of PTSD for the veteran and for the VA.
Intervention: Usual (PTSD) care plus Risperidone vs usual (PTSD) care plus placebo Study Abstract: Four hundred veterans with the diagnosis of military-related PTSD will be enrolled at 20 VAMC hospitals over a two-year period. An equipoise stratification design will be used to randomize patients in a double-blind manner to risperidone or placebo (\~200 patients in each group) for six months of treatment. Usual care will be provided for all patients for treatment of PTSD and other psychiatric and medical disorders. Comparisons between the risperidone and placebo groups will be made at the end of six months to answer the primary question. The sample size is calculated to give 90% power at the two-sided alpha level of 0.05 for the overall test for the CAPS score change.
STUDY UPDATE/NOTES: The study kicked-off in late July 2006 with recruitment expected to begin October 1, 2006.
Oct2006 - Participating sites are seeking approval for the protocol amendment which resulted from the Kick-Off meeting. Patient recruitment at each site will begin as soon as they receive approval of the amendment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 296
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sugar Pill Placebo Placebo 1 mg/day tablet for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day to a maximum of 4 mg/day allowed after a minimum of 4 weeks at the target dose 3 mg/day Risperidone Risperidone 1 mg/day tablet for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day to a maximum of 4 mg/day allowed after a minimum of 4 weeks at the target dose 3 mg/day
- Primary Outcome Measures
Name Time Method Change in CAPS Score From Baseline to Week 24 24 Weeks The primary outcome measure for this study was the total score on the 34-item Clinician-Administered PTSD Scale (CAPS). This study was the intent-to-treat analysis of the improvement in PTSD symptoms from baseline to week-24 follow-up as measured by the CAPS. Total score range for the CAPS is 0-136 with higher values representing a worse outcome. This study was powered initially to detect a 9-point difference between the treatment groups in the CAPS change score.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
VA Medical Center, Tuscaloosa
🇺🇸Tuscaloosa, Alabama, United States
VA Connecticut Health Care System (West Haven)
🇺🇸West Haven, Connecticut, United States
VA Greater Los Angeles Healthcare System, West LA
🇺🇸West Los Angeles, California, United States
New Mexico VA Health Care System, Albuquerque
🇺🇸Albuquerque, New Mexico, United States
VA Medical Center, Providence
🇺🇸Providence, Rhode Island, United States
Wlliam S. Middleton Memorial Veterans Hospital, Madison
🇺🇸Madison, Wisconsin, United States
Ralph H Johnson VA Medical Center, Charleston
🇺🇸Charleston, South Carolina, United States
Central Texas Veterans Health Care System
🇺🇸Temple, Texas, United States
VA Medical Center, Minneapolis
🇺🇸Minneapolis, Minnesota, United States
VA Medical Center, Durham
🇺🇸Durham, North Carolina, United States
VA San Diego Healthcare System, San Diego
🇺🇸San Diego, California, United States
Jesse Brown VAMC (WestSide Division)
🇺🇸Chicago, Illinois, United States
VA Medical Center, San Francisco
🇺🇸San Francisco, California, United States
VA Medical Center, Miami
🇺🇸Miami, Florida, United States
Atlanta VA Medical and Rehab Center, Decatur
🇺🇸Decatur, Georgia, United States
VA Maryland Health Care System, Baltimore
🇺🇸Baltimore, Maryland, United States
VA Medical Center, Jamaica Plain Campus
🇺🇸Boston, Massachusetts, United States
VA Salt Lake City Health Care System, Salt Lake City
🇺🇸Salt Lake City, Utah, United States
Michael E. DeBakey VA Medical Center (152)
🇺🇸Houston, Texas, United States
VA South Texas Health Care System, San Antonio
🇺🇸San Antonio, Texas, United States