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

NCT00624858 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2012-10-30

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Orexigen Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Susan McElroy, MD · University of Cincinnati

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00624858 on ClinicalTrials.gov