Clinical trial NCT00099983: Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder
Official title: CSP #504 - Risperidone Treatment for Military Service Related Chronic Post-Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress Disorders
Post-Traumatic
Keywords: PTSD
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Janssen, LP
First posted: 2004-12-22
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in CAPS Score From Baseline to Week 24
timeFrame: 24 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: VA Medical Center, Tuscaloosa
state: Alabama
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego
state: California
city: San Francisco
country: United States
facility: VA Medical Center, San Francisco
state: California
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West LA
state: California
city: West Haven
country: United States
facility: VA Connecticut Health Care System (West Haven)
state: Connecticut
city: Miami
country: United States
facility: VA Medical Center, Miami
state: Florida
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur
state: Georgia
city: Chicago
country: United States
facility: Jesse Brown VAMC (WestSide Division)
state: Illinois
city: Baltimore
country: United States
facility: VA Maryland Health Care System, Baltimore
state: Maryland
city: Boston
country: United States
facility: VA Medical Center, Jamaica Plain Campus
state: Massachusetts
city: Minneapolis
country: United States
facility: VA Medical Center, Minneapolis
state: Minnesota
city: Albuquerque
country: United States
facility: New Mexico VA Health Care System, Albuquerque
state: New Mexico
city: Durham
country: United States
facility: VA Medical Center, Durham
state: North Carolina
city: Providence
country: United States
facility: VA Medical Center, Providence
state: Rhode Island
city: Charleston
country: United States
facility: Ralph H Johnson VA Medical Center, Charleston
state: South Carolina
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center (152)
state: Texas
city: San Antonio
country: United States
facility: VA South Texas Health Care System, San Antonio
state: Texas
city: Temple
country: United States
facility: Central Texas Veterans Health Care System
state: Texas
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System, Salt Lake City
state: Utah
city: Madison
country: United States
facility: Wlliam S. Middleton Memorial Veterans Hospital, Madison
state: Wisconsin
Study officials:
affiliation: VA Connecticut Health Care System (West Haven)
name: John H. Krystal
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.