The purpose of this study is to determine if the combination of naltrexone SR and fluoxetine is more effective in treating the symptoms of obsessive-compulsive disorder (OCD)than either fluoxetine alone or naltrexone SR alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
8
Two week titration followed by daily dosing of fluoxetine 60 mg for 8 weeks. Response is assessed at after 8 weeks. Responders will continue on fluoxetine 60 mg for an additional 6 weeks. Non-responders will have naltrexone SR 32 mg added to their therapy.
Two week titration followed by daily dosing of naltrexone SR 32 mg and fluoxetine 60 mg for 8 weeks. Response is assessed at after 8 weeks. Responders will continue on a daily dose of naltrexone SR 32 mg and fluoxetine 60 mg for an additional 6 weeks. Non-responders will have their daily dose adjusted to naltrexone SR 48 mg and fluoxetine 80 mg.
Two week titration followed by daily dosing of naltrexone SR 32 mg for 8 weeks. Response is assessed at after 8 weeks. Responders will continue on naltrexone SR 32 mg for an additional 6 weeks. Non-responders will have fluoxetine 60 mg added to their therapy.
Synergy Clinical Research
National City, California, United States
California Clinical Trials
San Diego, California, United States
University of Florida, Department of Psychiatry
Gainesville, Florida, United States
Evaluate the mean change from baseline to Week 10 in total Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score between the combination treatment group versus fluoxetine alone and naltrexone SR alone
Time frame: Baseline to Week 10
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Atlanta Center for Medical Research
Atlanta, Georgia, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Global Medical Institute, LLC
Princeton, New Jersey, United States
Brooklyn Medical Institute
Brooklyn, New York, United States
Community Research
Cincinnati, Ohio, United States
Summit Research Network, Inc.
Portland, Oregon, United States
Carolina Clinical Research Services
Columbia, South Carolina, United States
...and 1 more locations