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

This study has been completed.
Sponsor:
Collaborator:
Janssen, LP
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00099983
First received: December 21, 2004
Last updated: April 11, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Stress Disorders, Post-Traumatic
Drug: Risperidone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CSP #504 - Risperidone Treatment for Military Service Related Chronic Post-Traumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in CAPS Score from Baseline to Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: October 2006
Study Completion Date: January 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
PTSD
Drug: Risperidone
atypical antipsychotic
Placebo Comparator: 2
PTSD
Drug: Placebo
Placebo

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099983

  Hide Study Locations
Locations
United States, Alabama
VA Medical Center, Tuscaloosa
Tuscaloosa, Alabama, United States, 35404
United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
VA Medical Center, San Francisco
San Francisco, California, United States, 94121
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
United States, Connecticut
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516
United States, Florida
VA Medical Center, Miami
Miami, Florida, United States, 33125
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, United States, 30033
United States, Illinois
Jesse Brown VAMC (WestSide Division)
Chicago, Illinois, United States, 60612
United States, Maryland
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201
United States, Massachusetts
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130
United States, Minnesota
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, New Mexico
New Mexico VA Health Care System, Albuquerque
Albuquerque, New Mexico, United States, 87108-5153
United States, North Carolina
VA Medical Center, Durham
Durham, North Carolina, United States, 27705
United States, Rhode Island
VA Medical Center, Providence
Providence, Rhode Island, United States, 02908
United States, South Carolina
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, United States, 29401-5799
United States, Texas
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
VA South Texas Health Care System, San Antonio
San Antonio, Texas, United States, 78229
Central Texas Veterans Health Care System
Temple, Texas, United States, 76504
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City
Salt Lake City, Utah, United States, 84148
United States, Wisconsin
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Janssen, LP
Investigators
Study Chair: John H. Krystal VA Connecticut Health Care System (West Haven)
  More Information

No publications provided by Department of Veterans Affairs

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Krystal, John - Study Chair, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00099983     History of Changes
Other Study ID Numbers: 504
Study First Received: December 21, 2004
Last Updated: April 11, 2011
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
PTSD

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 28, 2014