Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder

PHASE2CompletedINTERVENTIONAL
Enrollment

296

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

February 28, 2010

Study Completion Date

January 31, 2011

Conditions
Stress DisordersPost-Traumatic
Interventions
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.

DRUG

Placebo

Placebo

Trial Locations (20)

21201

VA Maryland Health Care System, Baltimore, Baltimore

27705

VA Medical Center, Durham, Durham

30033

Atlanta VA Medical and Rehab Center, Decatur, Decatur

33125

VA Medical Center, Miami, Miami

35404

VA Medical Center, Tuscaloosa, Tuscaloosa

53705

Wlliam S. Middleton Memorial Veterans Hospital, Madison, Madison

55417

VA Medical Center, Minneapolis, Minneapolis

60612

Jesse Brown VAMC (WestSide Division), Chicago

76504

Central Texas Veterans Health Care System, Temple

77030

Michael E. DeBakey VA Medical Center (152), Houston

78229

VA South Texas Health Care System, San Antonio, San Antonio

84148

VA Salt Lake City Health Care System, Salt Lake City, Salt Lake City

90073

VA Greater Los Angeles Healthcare System, West LA, West Los Angeles

92161

VA San Diego Healthcare System, San Diego, San Diego

94121

VA Medical Center, San Francisco, San Francisco

06516

VA Connecticut Health Care System (West Haven), West Haven

02130

VA Medical Center, Jamaica Plain Campus, Boston

87108-5153

New Mexico VA Health Care System, Albuquerque, Albuquerque

02908

VA Medical Center, Providence, Providence

29401-5799

Ralph H Johnson VA Medical Center, Charleston, Charleston

All Listed Sponsors
collaborator

Janssen, LP

INDUSTRY

lead

US Department of Veterans Affairs

FED

NCT00099983 - Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder | Biotech Hunter | Biotech Hunter