Civilian Post-Traumatic Stress Disorder Risperidone Clinical Trial
Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD
2 other identifiers
interventional
65
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2004
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 22, 2005
CompletedFirst Posted
Study publicly available on registry
August 24, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedAugust 19, 2015
August 1, 2015
2.4 years
August 22, 2005
August 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Remission of symptoms after 16 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- Janssen, LPcollaborator
Study Sites (3)
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Duke University Medical Center South
Durham, North Carolina, 27710, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Related Publications (1)
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.
PMID: 18278987DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara O Rothbaum, PHD
Emory University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 22, 2005
First Posted
August 24, 2005
Study Start
April 1, 2004
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
August 19, 2015
Record last verified: 2015-08