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

Phase 2

Completed

• Conditions: Depression
• Interventions: Drug: naltrexone SR 32 mg/ bupropion SR 360 mg daily

• Registration Number: NCT00624858
• Lead Sponsor: Orexigen Therapeutics, Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-19
• Study First Submitted QC: 2008-02-26
• Study First Posted: 2008-02-27
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2012-10
• Disposition First Submitted: 2012-10-23
• Disposition First Submitted QC: 2012-10-23
• Last Update Submitted: 2012-10-23
• Disposition First Posted: 2012-10-30
• Last Update Posted: 2012-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NB32	naltrexone SR 32 mg/ bupropion SR 360 mg daily	Naltrexone SR 32 mg/Bupropion SR 360 mg/ day

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To assess the percentage change from baseline in total body weight at 12 and 24 weeks.	12 and 24 weeks

Trial Locations

Locations (1)

Lindner Center of HOPE; 🇺🇸 Mason, Ohio, United States