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

NCT ID: NCT00624858

Last Updated: 2012-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-07-31

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.

Conditions

Depression

Keywords

Depression; depressed; overweight; obese

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NB32

Naltrexone SR 32 mg/Bupropion SR 360 mg/ day

Group Type: EXPERIMENTAL

naltrexone SR 32 mg/ bupropion SR 360 mg daily

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orexigen Therapeutics, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan McElroy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

Lindner Center of HOPE

Mason, Ohio, United States

Countries

United States

References

McElroy SL, Guerdjikova AI, Kim DD, Burns C, Harris-Collazo R, Landbloom R, Dunayevich E. Naltrexone/Bupropion combination therapy in overweight or obese patients with major depressive disorder: results of a pilot study. Prim Care Companion CNS Disord. 2013;15(3):PCC.12m01494. doi: 10.4088/PCC.12m01494. Epub 2013 Jun 20.

Reference Type: DERIVED

PMID: 24171147 (View on PubMed)

Other Identifiers

NB-402

Identifier Type: -

Identifier Source: org_study_id