Risperidone Augmentation for PTSD

Completed · Phase 2/Phase 3

Conditions studied: Post-Traumatic Stress Disorder

In brief

The purpose of this study is to (1) compare the response of civilians with Posttraumatic Stress Disorder(PTSD) currently receiving sertraline without an optimal response to risperidone augmentation vs. placebo, and (2) to evaluate the tolerability of risperidone augmentation, and (3) to identifiy predictors of response to risperidone augmentation. the hypothesis is that risperidone augmentation of sertraline treatment of PTSD is safe and effective.

Key facts

Study ID

NCT00215241

Run by

Duke University

People needed

80

Starts

2004-04-01

Expected to finish

2006-07-01

Last updated by the study team

2014-09-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed consent prior to any study procedures being done
• Male or female outpatients between 18-65 years of age
• Trauma experienced meets trauma defined by DSM
• Meets criteria for DSM-IV PTSD as a result of civilian trauma
• CAPS Score of greater than or equal to 50 at screening and baseline
• Able to swallow whole capsules
• Fluency in both written and spoken English
• Negative urine drug screen at screening visit
• If female of childbearing potential, must have negative serum pregnancy test at screening visit and must agree to use a medically accepted means of contraception throughout the study and for 30 days after completion of the study
• To be include in Phase 2, must complete Phase I and must have less than 70% reduction from baseline on the CAPS

You may not qualify if…

• Pregnant women or those likely to become pregnant, or nursing mothers
• Medical instability (clinically significant hepatic, cardiac, or pulmonary disease, HIV, uncontrolled hypertension, diabetes or thyroid conditions, seizure disorders, clinically significant laboratory abnormalities at screen
• Primary psychotic disorder, or history of schizophrenia, other psychotic disorder, bipolar disorder, or cognitive disorder
• Those considered a risk for suicidal or homicidal behavior (the clinician will immediately, upon assessing a risk for suicidal or homicidal behavior, refer the patient for further evaluation and probable hospitalization)
• Hypersensitivity or other contraindication to sertraline or risperidone
• Meeting DSM-IV criteria for drug or alcohol dependence within 3 months of study entry
• Those who are still experiencing an ongoing traumatic stressor (domestic violence/elder abuse) who will need to focus on safety (the clinician will make referrals as appropriate)
• DSM-IV primary diagnosis of any other anxiety disorder or major depressive disorder
• Current use of antipsychotic, or other psychotropic medications, or supplements with known psychotropic effects
• Current involvement in litigation related to PTSD
• Current psychotherapy aimed at treating PTSD
• PTSD as a result of combat-related trauma
• Previous failure to respond to sertraline-risperidone combination at therapeutic dose

Where it is running

• Emory University Medical Center — Atlanta, Georgia, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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