Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial
- Conditions
- Post-Traumatic Stress Disorders
- Registration Number
- NCT00133822
- Lead Sponsor
- Emory University
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Remission of symptoms after 16 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Duke University Medical Center South
🇺🇸Durham, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States