Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial

Post-Traumatic Stress Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00133822
• Other study ID #: 0184-2004
• Secondary ID: RIS-EMR-4005
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 22, 2005
• Last updated: August 18, 2015
• Start date: April 2004
• Est. completion date: September 2006

Study information

• Verified date: August 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Sertraline and Risperidone

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Duke University Medical Center South	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Janssen, LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission of symptoms after 16 weeks