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

Orexigen Therapeutics, Inc1 site in 1 country25 target enrollmentJanuary 2008

ConditionsDepression

Interventionsnaltrexone SR 32 mg/ bupropion SR 360 mg daily

Drugsnaltrexone SR 32 mg/ bupropion SR 360 mg daily

Overview

Phase: Phase 2
Intervention: naltrexone SR 32 mg/ bupropion SR 360 mg daily
Conditions: Depression
Sponsor: Orexigen Therapeutics, Inc
Enrollment: 25
Locations: 1
Primary Endpoint: To assess the change in depressive symptoms as measured by Montgomery-Asberg Depression Rating Scale (MADRS) total score at 12 weeks
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

July 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Orexigen Therapeutics, Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female and male subjects must be 18 to 65 years of age;
•Have body mass index (BMI) greater or equal to 27 and less than or to equal 43kg/m2;
•Meet criteria for major depression
•Women of child-bearing potential, must be non-lactating and agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug;
•Able to comply with all required study procedures and schedule;
•Able to speak and read English;
•Willing and able to give written informed consent

Exclusion Criteria

•Obesity of known endocrine origin
•Serious medical condition
•History of drug or alcohol abuse or dependence
•Use of excluded concomitant medications
•History of surgical or device (e.g. gastric banding) intervention for obesity;
•History or predisposition to seizures
•Pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug;
•Planned surgical procedure that can impact the conduct of the study;
•Use of investigational drug, device or procedure within 30 days prior to Screening;
•Participation in any previous clinical trial conducted by Orexigen Therapeutics;