Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder

Stress Disorders Clinical Trial

— CSP #504  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099983
• Other study ID #: 504
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2004
• Last updated: August 5, 2014
• Start date: October 2006
• Est. completion date: January 2011

Study information

• Verified date: August 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: January 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Post-Traumatic
• Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Risperidone
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.
• Placebo
Placebo

Locations

Country	Name	City	State
United States	New Mexico VA Health Care System, Albuquerque	Albuquerque	New Mexico
United States	VA Maryland Health Care System, Baltimore	Baltimore	Maryland
United States	VA Medical Center, Jamaica Plain Campus	Boston	Massachusetts
United States	Ralph H Johnson VA Medical Center, Charleston	Charleston	South Carolina
United States	Jesse Brown VAMC (WestSide Division)	Chicago	Illinois
United States	Atlanta VA Medical and Rehab Center, Decatur	Decatur	Georgia
United States	VA Medical Center, Durham	Durham	North Carolina
United States	Michael E. DeBakey VA Medical Center (152)	Houston	Texas
United States	Wlliam S. Middleton Memorial Veterans Hospital, Madison	Madison	Wisconsin
United States	VA Medical Center, Miami	Miami	Florida
United States	VA Medical Center, Minneapolis	Minneapolis	Minnesota
United States	VA Medical Center, Providence	Providence	Rhode Island
United States	VA Salt Lake City Health Care System, Salt Lake City	Salt Lake City	Utah
United States	VA South Texas Health Care System, San Antonio	San Antonio	Texas
United States	VA San Diego Healthcare System, San Diego	San Diego	California
United States	VA Medical Center, San Francisco	San Francisco	California
United States	Central Texas Veterans Health Care System	Temple	Texas
United States	VA Medical Center, Tuscaloosa	Tuscaloosa	Alabama
United States	VA Connecticut Health Care System (West Haven)	West Haven	Connecticut
United States	VA Greater Los Angeles Healthcare System, West LA	West Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Janssen, LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No