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

Orexigen

Status and phase

Completed

Phase 2

Conditions

Depression

Treatments

Drug: naltrexone SR 32 mg/ bupropion SR 360 mg daily

Study type

Interventional

Funder types

Industry

Identifiers

NCT00624858

NB-402

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.