Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00133822|
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : August 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Stress Disorders||Drug: Sertraline and Risperidone||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD|
|Study Start Date :||April 2004|
|Primary Completion Date :||September 2006|
|Study Completion Date :||September 2006|
- Remission of symptoms after 16 weeks
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): NCT00133822
|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|