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Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial

Primary Purpose

Post-Traumatic Stress Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sertraline and Risperidone
Sponsored by
Emory University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorders focused on measuring Post-Traumatic Stress Disorder, Sertraline, Risperidone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Emory University School of Medicine
  • Duke University Medical Center South
  • Medical University of South Carolina

Outcomes

Primary Outcome Measures

Remission of symptoms after 16 weeks

Secondary Outcome Measures

Full Information

First Posted
August 22, 2005
Last Updated
August 18, 2015
Sponsor
Emory University
Collaborators
Janssen, LP
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1. Study Identification

Unique Protocol Identification Number
NCT00133822
Brief Title
Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial
Official Title
Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Janssen, LP

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorders
Keywords
Post-Traumatic Stress Disorder, Sertraline, Risperidone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
65 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sertraline and Risperidone
Primary Outcome Measure Information:
Title
Remission of symptoms after 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara O Rothbaum, PHD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Duke University Medical Center South
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18278987
Citation
Rothbaum BO, Killeen TK, Davidson JR, Brady KT, Connor KM, Heekin MH. Placebo-controlled trial of risperidone augmentation for selective serotonin reuptake inhibitor-resistant civilian posttraumatic stress disorder. J Clin Psychiatry. 2008 Apr;69(4):520-5. doi: 10.4088/jcp.v69n0402.
Results Reference
derived

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Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial

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