Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder
NCT ID: NCT00099983
Last Updated: 2014-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
296 participants
INTERVENTIONAL
2006-10-31
2011-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Risperidone
Initiate treatment with a low dose (1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day). Reduction to a lower dose will be allowed at any time, based on adverse effects. Treatment will continue for 6 months. Patients who discontinue treatment will be allowed to resume treatment at any time.
Sugar Pill
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
Placebo
Placebo
Interventions
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Risperidone
Initiate treatment with a low dose (1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day). Reduction to a lower dose will be allowed at any time, based on adverse effects. Treatment will continue for 6 months. Patients who discontinue treatment will be allowed to resume treatment at any time.
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Military service related chronic PTSD
* CAPS score \>50
* Participant in VA outpatient PTSD clinic
* History of non-response to two or more antidepressants
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Janssen, LP
INDUSTRY
US Department of Veterans Affairs
FED
Responsible Party
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Principal Investigators
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John H. Krystal
Role: STUDY_CHAIR
VA Connecticut Health Care System (West Haven)
Locations
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VA Medical Center, Tuscaloosa
Tuscaloosa, Alabama, United States
VA San Diego Healthcare System, San Diego
San Diego, California, United States
VA Medical Center, San Francisco
San Francisco, California, United States
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States
VA Medical Center, Miami
Miami, Florida, United States
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, United States
Jesse Brown VAMC (WestSide Division)
Chicago, Illinois, United States
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States
New Mexico VA Health Care System, Albuquerque
Albuquerque, New Mexico, United States
VA Medical Center, Durham
Durham, North Carolina, United States
VA Medical Center, Providence
Providence, Rhode Island, United States
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, 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
Central Texas Veterans Health Care System
Temple, Texas, United States
VA Salt Lake City Health Care System, Salt Lake City
Salt Lake City, Utah, United States
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, United States
Countries
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References
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Krystal JH, Pietrzak RH, Rosenheck RA, Cramer JA, Vessicchio J, Jones KM, Huang GD, Vertrees JE, Collins J, Krystal AD; Veterans Affairs Cooperative Study #504 Group. Sleep disturbance in chronic military-related PTSD: clinical impact and response to adjunctive risperidone in the Veterans Affairs cooperative study #504. J Clin Psychiatry. 2016 Apr;77(4):483-91. doi: 10.4088/JCP.14m09585.
Krystal JH, Rosenheck RA, Cramer JA, Vessicchio JC, Jones KM, Vertrees JE, Horney RA, Huang GD, Stock C; Veterans Affairs Cooperative Study No. 504 Group. Adjunctive risperidone treatment for antidepressant-resistant symptoms of chronic military service-related PTSD: a randomized trial. JAMA. 2011 Aug 3;306(5):493-502. doi: 10.1001/jama.2011.1080.
Other Identifiers
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504
Identifier Type: -
Identifier Source: org_study_id
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