8
Participants
Start Date
September 30, 2008
Primary Completion Date
December 31, 2008
Study Completion Date
December 31, 2008
Fluoxetine 60 mg
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.
Naltrexone 32 mg and fluoxetine 60 mg
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.
Naltrexone SR 32 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.
Brooklyn Medical Institute, Brooklyn
Carolina Clinical Research Services, Columbia
Atlanta Center for Medical Research, Atlanta
University of Florida, Department of Psychiatry, Gainesville
Community Research, Cincinnati
Indiana University School of Medicine, Indianapolis
Northbrooke Research Center, Brown Deer
Synergy Clinical Research, National City
California Clinical Trials, San Diego
Summit Research Network, Inc., Portland
Global Medical Institute, LLC, Princeton
Lead Sponsor
Orexigen Therapeutics, Inc
INDUSTRY