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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2004-08-31

Brief Summary

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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

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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.

Conditions

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Post-Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Risperidone

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Frederick Petty, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

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Creighton University Psychiatry and Research Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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RIS-USA-245B

Identifier Type: -

Identifier Source: org_study_id