Status:
COMPLETED
Risperidone in the Treatment of PTSD in Women Survivors of Domestic Abuse and Rape Trauma
Lead Sponsor:
Creighton University
Collaborating Sponsors:
Janssen, LP
Conditions:
Post-Traumatic Stress Disorder
Eligibility:
FEMALE
19-64 years
Phase:
PHASE4
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 risperido...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
End Date :
August 1 2004
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00208182
Start Date
July 1 2001
End Date
August 1 2004
Last Update
March 10 2006
Active Locations (1)
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1
Creighton University Psychiatry and Research Center
Omaha, Nebraska, United States, 68131