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

NCT00208182 | Completed Phase 4

• 1 other identifier: RIS-USA-245B
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (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 Outcomes (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.

Interventions

Risperidone DRUG

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Creighton University: lead
• Janssen, LP: collaborator

Study Sites (1)

Creighton University Psychiatry and Research Center

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Frederick Petty, MD, PhD

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: July 1, 2001
• Study Completion: August 1, 2004
• Last Updated: March 10, 2006

Record last verified: 2006-03

Locations

US (1)