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

Launched by OREXIGEN THERAPEUTICS, INC · Feb 26, 2008

Keywords

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Gender

ALL

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