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

• ClinicalTrials.gov Identifier: NCT00208182
• Recruitment Status: Completed
• First Posted: September 21, 2005
• Last Update Posted: March 10, 2006
• Sponsor: Creighton University
• Collaborator: Janssen, LP
• Information provided by: Creighton University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Post-Traumatic Stress Disorder	Drug: Risperidone	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Prevention
• 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
• Study Start Date: July 2001
• Study Completion Date: August 2004

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 64 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Nebraska

Creighton University Psychiatry and Research Center

Omaha, Nebraska, United States, 68131

Sponsors and Collaborators

Creighton University

Janssen, LP

Investigators

• Principal Investigator: Frederick Petty, MD, PhD; Creighton University

More Information

• ClinicalTrials.gov Identifier: NCT00208182 History of Changes
• Other Study ID Numbers: RIS-USA-245B
• First Posted: September 21, 2005
• Last Update Posted: March 10, 2006
• Last Verified: March 2006

Additional relevant MeSH terms:

Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Risperidone; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Dopamine Antagonists; Dopamine Agents