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

Creighton University

Status and phase

Completed

Phase 4

Conditions

Post-Traumatic Stress Disorder

Treatments

Drug: Risperidone

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00208182

RIS-USA-245B

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

19 to 64 years old

Volunteers

Accepts Healthy Volunteers

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.