Risperidone in the Treatment of PTSD in Women Survivors of Domestic Abuse and Rape Trauma

Post-Traumatic Stress Disorder Clinical Trial

Official title: Risperidone Monotherapy in the Treatment of PTSD in Women Survivors of Domestic Abuse and Rape Trauma: a Double-Blind, Placebo Controlled, Randomized Clinical Trial

Status Completed

Clinical Trial Summary

This medical study is an assessment of clinical response in women with Posttraumatic Stress Disorder (PTSD) due to domestic violence or rape trauma when treated with risperidone. Response to risperidone or placebo (inactive drug) is measured by Clinician Administered PTSD Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8). Second, the effect of risperidone on depressive and anxiety symptoms will be assessed using the Hamilton Rating Scale for Anxiety, Hamilton Rating Scale for Depression and the Clinical Global Impression.

Clinical Trial Description

Risperidone is an atypical antipsychotic that has been shown to be effective in both the core PTSD symptoms and psychotic symptoms associated with combat-induced PTSD in males. Case series have shown that risperidone is possibly effective in monotherapy or adjunctively in treating PTSD patients. However, risperidone has never been tested in women with severe PTSD. Thus, we propose extending and expanding this research to another antipsychotic, risperidone, in a cohort of women who suffer PTSD as a consequence of domestic violence and/or rape trauma. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

• NCT number: NCT00208182
• Study type: Interventional
• Source: Creighton University
• Status: Completed
• Phase: Phase 4
• Start date: July 2001
• Completion date: August 2004