Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development
• Collaborator: Janssen, LP
• Treatments: Risperidone

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