Status:
COMPLETED
A Study of Naltrexone SR/ Bupropion SR in Overweight or Obese Subjects With Major Depression
Lead Sponsor:
Orexigen Therapeutics, Inc
Conditions:
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00624858
Start Date
January 1 2008
End Date
July 1 2009
Last Update
October 30 2012
Active Locations (1)
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1
Lindner Center of HOPE
Mason, Ohio, United States, 45040