NCT00133822

Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial

Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 65 (planned)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Post-Traumatic Stress Disorders

Interventions

Type	Name	Description
DRUG	Sertraline and Risperidone

Timeline

• Start date: 2004-04-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2005-08-24
• Last updated: 2015-08-19

Locations

3 sites across 1 country: United States