NCT00208182

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: Creighton University · Academic / Other
• Sex: Female
• Age: 19 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Post-Traumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Risperidone

Timeline

• Start date: 2001-07-01
• Completion: 2004-08-01
• First posted: 2005-09-21
• Last updated: 2006-03-10

Locations

1 site across 1 country: United States