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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Collaborator: |
Janssen, LP |
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00099983 |
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: Placbo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study |
| Official Title: | CSP #504 - Risperidone Treatment for Military Service Related Chronic Post-Traumatic Stress Disorder |
| Estimated Enrollment: | 400 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
PTSD
|
Drug: Risperidone
atypical antipsychotic
|
|
2: Placebo Comparator
PTSD
|
Drug: Placbo
Placebo
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| VA Medical Center, Tuscaloosa | |
| Tuscaloosa, Alabama, United States, 35404 | |
| United States, California | |
| VA Medical Center, San Francisco | |
| San Francisco, California, United States, 94121 | |
| VA San Diego Healthcare System, San Diego | |
| San Diego, California, United States, 92161 | |
| 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 | |
| Study Chair: | John H. Krystal | VA Connecticut Health Care System (West Haven) |
More Information
| Responsible Party: | Department of Veterans Affairs ( Krystal, John - Study Chair ) |
| Study ID Numbers: | 504 |
| Study First Received: | December 21, 2004 |
| Last Updated: | September 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00099983 History of Changes |
| Health Authority: | United States: Federal Government |
|
PTSD |
|
Neurotransmitter Agents Tranquilizing Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Risperidone Central Nervous System Depressants Stress Dopamine Antagonists Antipsychotic Agents |
Stress Disorders, Traumatic Pharmacologic Actions Serotonin Antagonists Pathologic Processes Serotonin Agents Anxiety Disorders Mental Disorders Therapeutic Uses Stress Disorders, Post-Traumatic Dopamine Agents Central Nervous System Agents |
