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.
Post-Traumatic Stress Disorders
Drug: Sertraline and Risperidone
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD|
- Remission of symptoms after 16 weeks
|Study Start Date:||April 2004|
|Study Completion Date:||September 2006|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
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.
|United States, Georgia|
|Emory University School of Medicine|
|Atlanta, Georgia, United States, 30322|
|United States, North Carolina|
|Duke University Medical Center South|
|Durham, North Carolina, United States, 27710|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States|
|Principal Investigator:||Barbara O Rothbaum, PHD||Emory University|