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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Depression

Intervention / Treatment
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* Drug: naltrexone SR 32 mg/ bupropion SR 360 mg daily


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NB32<br>Naltrexone SR 32 mg/Bupropion SR 360 mg/ day | Drug: naltrexone SR 32 mg/ bupropion SR 360 mg daily<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the change in depressive symptoms as measured by Montgomery-Asberg Depression Rating Scale (MADRS) total score at 12 weeks |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the percentage change from baseline in total body weight at 12 and 24 weeks. |  | 12 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, depressed, overweight, obese