At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Chronic PTSD related to military service
- ✓CAPS score greater than 50
- ✓Currently in VA outpatient PTSD clinic
- ✕Comorbid Axis I disorder requiring antipsychotic medication
- ✕Substance dependence (excluding nicotine)
- ✕Hepatic or renal impairment
- ✕Incompatible medical diagnoses or medications (e.g., coumadin, insulin)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
CSP #504 - Risperidone Treatment for Military Service Related Chronic Post-Traumatic Stress Disorder
In Brief
A Phase 2 clinical trial evaluating Risperidone and Placebo for Stress Disorders and Post-Traumatic. Completed, enrolled 296 participants across 20 sites.
Detailed 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.
Study Details
Timeline
Interventions
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