Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder
CSP #504
CSP #504 - Risperidone Treatment for Military Service Related Chronic Post-Traumatic Stress Disorder
1 other identifier
interventional
296
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2006
Typical duration for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2004
CompletedFirst Posted
Study publicly available on registry
December 22, 2004
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
August 22, 2014
CompletedAugust 22, 2014
August 1, 2014
3.3 years
December 21, 2004
August 6, 2013
August 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in CAPS Score From Baseline to Week 24
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.
24 Weeks
Study Arms (2)
Risperidone
ACTIVE COMPARATOR1 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
Sugar Pill
PLACEBO COMPARATORPlacebo 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- US Department of Veterans Affairslead
- Janssen, LPcollaborator
Study Sites (20)
VA Medical Center, Tuscaloosa
Tuscaloosa, Alabama, 35404, United States
VA San Diego Healthcare System, San Diego
San Diego, California, 92161, United States
VA Medical Center, San Francisco
San Francisco, California, 94121, United States
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073, United States
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, 06516, United States
VA Medical Center, Miami
Miami, Florida, 33125, United States
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, 30033, United States
Jesse Brown VAMC (WestSide Division)
Chicago, Illinois, 60612, United States
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, 21201, United States
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, 02130, United States
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417, United States
New Mexico VA Health Care System, Albuquerque
Albuquerque, New Mexico, 87108-5153, United States
VA Medical Center, Durham
Durham, North Carolina, 27705, United States
VA Medical Center, Providence
Providence, Rhode Island, 02908, United States
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, 29401-5799, United States
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030, United States
VA South Texas Health Care System, San Antonio
San Antonio, Texas, 78229, United States
Central Texas Veterans Health Care System
Temple, Texas, 76504, United States
VA Salt Lake City Health Care System, Salt Lake City
Salt Lake City, Utah, 84148, United States
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, 53705, United States
Related Publications (2)
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.
PMID: 26890894DERIVEDKrystal 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.
PMID: 21813427DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Krystal, MD
- Organization
- VA Connecticut HCS
Study Officials
- STUDY CHAIR
John H. Krystal
VA Connecticut Health Care System (West Haven)
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2004
First Posted
December 22, 2004
Study Start
October 1, 2006
Primary Completion
February 1, 2010
Study Completion
January 1, 2011
Last Updated
August 22, 2014
Results First Posted
August 22, 2014
Record last verified: 2014-08