Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial
The purpose of this study is to determine whether the administration of risperidone is effective in the treatment of selective serotonin reuptake inhibitor (SSRI)-resistant post-traumatic stress disorder (PTSD) in civilians...
Brief Summary
Official Title: “Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD”
The purpose of this study is to determine whether the administration of risperidone is effective in the treatment of selective serotonin reuptake inhibitor (SSRI)-resistant post-traumatic stress disorder (PTSD) in civilians.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Detailed Clinical Trial Description
Individuals with PTSD often experience anxiety attacks, nightmares, or repeated unwanted memories after experiencing or witnessing life-threatening events, such as serious accidents or natural disasters, or traumatic events such as physical or sexual abuse.
Risperidone has been approved by the Food and Drug Administration for the treatment of psychotic disorders and has been found helpful for PTSD and depression, but is still considered investigational for the purposes of this study.
All qualified participants will be started on sertraline (Zoloft) for eight weeks. Patients who are still symptomatic at the end of this phase, will be invited to join the second portion of the study where they will be randomly assigned to receive risperidone or placebo (sugar pill) in addition to the sertraline. Participants will be monitored regularly for medication effects, adverse events, and PTSD symptoms.
Intervention(s) in this Clinical Trial
- Drug: Sertraline and Risperidone
Outcome Measures for this Clinical Trial
Primary Measures
- Remission of symptoms after 16 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Meets criteria for DSM-IV PTSD for a minimum of one month duration
- Clinician-Administered PTSD Scale (CAPS) score > or = to 50
- Able to read and complete questionnaires and interviews
- Negative urine drug screen
Exclusion Criteria:
- Pregnant or nursing
- Primary psychotic disorder; psychotic disorder; or cognitive disorder.
- Prominent suicidal or homicidal ideation
- Alcohol or substance dependence within 3 months of starting study
- Primary anxiety disorder or bipolar disorder
- Patients currently being treated with antipsychotic medication
- Patients in active psychotherapy aimed at PTSD
- Combat-related PTSD
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: Emory University Other
Overall Clinical Trial Officials and Contacts
Barbara O Rothbaum, PHD Principal Investigator Emory University
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00133822
Study ID Number: RIS-EMR-4005
ClinicalTrials.gov Identifier: NCT00133822
Health Authority: United States: Institutional Review Board
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00133822
