Back to resultsRisperidone in the Treatment of PTSD in Women Survivors of Domestic Abuse and Rape Trauma
Primary Purpose
Post-Traumatic Stress Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Risperidone
Sponsored by
About this trial
This is an interventional prevention trial for Post-Traumatic Stress Disorder
Eligibility 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.
Sites / Locations
- Creighton University Psychiatry and Research Center
Outcomes
Primary Outcome Measures
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
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.
Full Information
NCT ID
NCT00208182
First Posted
September 13, 2005
Last Updated
March 8, 2006
Sponsor
Creighton University
Collaborators
Janssen, LP
1. Study Identification
Unique Protocol Identification Number
NCT00208182
Brief Title
Risperidone in the Treatment of PTSD in Women Survivors of Domestic Abuse and Rape Trauma
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 Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Creighton University
Collaborators
Janssen, LP
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Risperidone
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick Petty, MD, PhD
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University Psychiatry and Research Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Risperidone in the Treatment of PTSD in Women Survivors of Domestic Abuse and Rape Trauma
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