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

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.

Study Overview

• Status: Completed
• Conditions: Post-Traumatic Stress Disorder
• Intervention / Treatment: Drug: Risperidone

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.

• Study Type: Interventional
• Enrollment: 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Creighton University Psychiatry and Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women with DSM-IV clinical diagnosis of PTSD caused by domestic violence or rape, who are able to attend weekly clinic appointments;
• Age 19 -64, not pregnant and either sterile or using acceptable contraception;
• A willingness and ability to provide competent signed informed consent;
• A level of understanding sufficient to perform all tests and examinations required by the protocol (including fluency of spoken English).

Exclusion Criteria:

• Any diagnosis of schizophrenia or bipolar I disorder; or active substance dependence.
• Unstable general medical condition or serious illness (e.g., death or hospitalization is anticipated within one year), poor liver or kidney function-Subjects with prior non-response to risperidone for the treatment of PTSD with an adequate trial
• Enrolment in any drug study within the last 60 days.
• Pregnancy or nursing.
• Any subject judged clinically to be at serious suicidal risk in the opinion of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To compare the response in PTSD symptoms in women survivors of domestic violence or rape when treated with risperidone v. placebo, as measured by the Clinician Administered PTSD Scale (CAPS), and the TOP-8.

Secondary Outcome Measures

Outcome Measure
To assess the effect of risperidone on depressive and anxiety symptoms in this study population. Instruments used include Hamilton Rating Scale for Anxiety, Hamilton Rating Scale for Depression and the Clinical Global Impression.

Collaborators and Investigators

• Sponsor: Creighton University
• Collaborators: Janssen, LP
• Investigators: Principal Investigator: Frederick Petty, MD, PhD, Creighton University

Study record dates

Study Major Dates

• Study Start: July 1, 2001
• Study Completion: August 1, 2004

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): March 10, 2006
• Last Update Submitted That Met QC Criteria: March 8, 2006
• Last Verified: March 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: RIS-USA-245B