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Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder

Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stress Disorders; Post-Traumatic

Intervention: Risperidone (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Department of Veterans Affairs

Official(s) and/or principal investigator(s):
John H. Krystal, Study Chair, Affiliation: VA Connecticut Health Care System (West Haven)


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.

Clinical Details

Official title: CSP #504 - Risperidone Treatment for Military Service Related Chronic Post-Traumatic Stress Disorder

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in CAPS Score From Baseline to Week 24

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

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

Additional Information

Starting date: October 2006
Last updated: August 5, 2014

Page last updated: August 23, 2015

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