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

Official Title: “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”

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.

Intervention(s) in this Clinical Trial

• Drug: naltrexone SR 32 mg/ bupropion SR 360 mg daily
  • All subjects are to complete a 4 week titration period at which time subjects will be titrated up to a maintenance level of study drug. Subjects will then take the maintenance dose of study drug for an additional 20 weeks. During the study, subjects will receive ancillary therapy including advice on diet and exercise

Primary Measures

• To assess the change in depressive symptoms as measured by Montgomery-Asberg Depression Rating Scale (MADRS) total score at 12 weeks
  • Time Frame: 12 Weeks
    Safety Issue?: No

Secondary Measures

• To assess the percentage change from baseline in total body weight at 12 and 24 weeks.
  • Time Frame: 12 and 24 weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Orexigen Therapeutics, Inc Industry

Overall Clinical Trial Officials and Contacts

Susan McElroy, MD Principal Investigator University of Cincinnati  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00624858

Study ID Number: NB-402

ClinicalTrials.gov Identifier: NCT00624858

Health Authority: United States: Food and Drug Administration