Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00624858
First received: February 19, 2008
Last updated: October 23, 2012
Last verified: October 2012
History of Changes

February 19, 2008
October 23, 2012
January 2008
July 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00624858 on ClinicalTrials.gov Archive Site
To assess the percentage change from baseline in total body weight at 12 and 24 weeks. [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Naltrexone SR/ Bupropion SR in Overweight or Obese Subjects With Major Depression
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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
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
Experimental: NB32
Naltrexone SR 32 mg/Bupropion SR 360 mg/ day
Intervention: Drug: naltrexone SR 32 mg/ bupropion SR 360 mg daily
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00624858
NB-402
No
Orexigen Therapeutics, Inc
Orexigen Therapeutics, Inc
Not Provided
Principal Investigator: Susan McElroy, MD University of Cincinnati
Orexigen Therapeutics, Inc
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP