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

This study has been completed.
Sponsor:
Collaborator:
Janssen, LP
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT00208182
First received: September 13, 2005
Last updated: March 8, 2006
Last verified: March 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Post-Traumatic Stress Disorder
 Drug: Risperidone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Drug Information available for: Risperidone
U.S. FDA Resources

Further study details as provided by Creighton University:

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.

Estimated Enrollment: 20
Study Start Date: July 2001
Estimated Study Completion Date: August 2004
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.

  Eligibility

Ages Eligible for Study:   19 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208182

Locations
United States, Nebraska
Creighton University Psychiatry and Research Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Janssen, LP
Investigators
Principal Investigator: Frederick Petty, MD, PhD Creighton University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00208182     History of Changes
Other Study ID Numbers: RIS-USA-245B
Study First Received: September 13, 2005
Last Updated: March 8, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 16, 2013