Risperidone in the Treatment of PTSD in Women Survivors of Domestic Abuse and Rape Trauma
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ClinicalTrials.gov Identifier: NCT00208182 |
Recruitment Status :
Completed
First Posted : September 21, 2005
Last Update Posted : March 10, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Post-Traumatic Stress Disorder | Drug: Risperidone | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
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 Start Date : | July 2001 |
Study Completion Date : | August 2004 |

- 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.
- 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.

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Ages Eligible for Study: | 19 Years to 64 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208182
United States, Nebraska | |
Creighton University Psychiatry and Research Center | |
Omaha, Nebraska, United States, 68131 |
Principal Investigator: | Frederick Petty, MD, PhD | Creighton University |
ClinicalTrials.gov Identifier: | NCT00208182 History of Changes |
Other Study ID Numbers: |
RIS-USA-245B |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | March 10, 2006 |
Last Verified: | March 2006 |
Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents |