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

Primary Purpose

Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
naltrexone SR 32 mg/ bupropion SR 360 mg daily
Sponsored by
Orexigen Therapeutics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, depressed, overweight, obese

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lindner Center of HOPE

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NB32

Arm Description

Naltrexone SR 32 mg/Bupropion SR 360 mg/ day

Outcomes

Primary Outcome Measures

To assess the change in depressive symptoms as measured by Montgomery-Asberg Depression Rating Scale (MADRS) total score at 12 weeks

Secondary Outcome Measures

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

Full Information

First Posted
February 19, 2008
Last Updated
October 23, 2012
Sponsor
Orexigen Therapeutics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00624858
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orexigen Therapeutics, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, depressed, overweight, obese

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NB32
Arm Type
Experimental
Arm Description
Naltrexone SR 32 mg/Bupropion SR 360 mg/ day
Intervention Type
Drug
Intervention Name(s)
naltrexone SR 32 mg/ bupropion SR 360 mg daily
Intervention Description
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 Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To assess the percentage change from baseline in total body weight at 12 and 24 weeks.
Time Frame
12 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan McElroy, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lindner Center of HOPE
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24171147
Citation
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.
Results Reference
derived

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

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