NCT00624858

A Study of Naltrexone SR/ Bupropion SR in Overweight or Obese Subjects With Major Depression

An Open-Label Study Assessing the Safety and Efficacy of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) in Overweight or Obese Subjects With Major Depression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Orexigen Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in the treatment of major depression in overweight or obese subjects.

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	naltrexone SR 32 mg/ bupropion SR 360 mg daily	All subjects are to complete a 4 week titration period at which time subjects will be titrated up to a maintenance level of study drug. Subjects will then take the maintenance dose of study drug for an additional 20 weeks. During the study, subjects will receive ancillary therapy including advice on diet and exercise

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-02-27
• Last updated: 2012-10-30

Locations

1 site across 1 country: United States