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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orexigen Therapeutics, Inc
• Treatments: Bupropion; Naltrexone

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;

• Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in the study.