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
  Purpose

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.


Condition Intervention Phase
Depression
Drug: naltrexone SR 32 mg/ bupropion SR 360 mg daily
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Orexigen Therapeutics, Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 25
Study Start Date: January 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NB32
Naltrexone SR 32 mg/Bupropion SR 360 mg/ day
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


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624858

Locations
United States, Ohio
Lindner Center of HOPE
Mason, Ohio, United States, 45040
Sponsors and Collaborators
Orexigen Therapeutics, Inc
Investigators
Principal Investigator: Susan McElroy, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT00624858     History of Changes
Other Study ID Numbers: NB-402
Study First Received: February 19, 2008
Last Updated: October 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Orexigen Therapeutics, Inc:
Depression
depressed
overweight
obese

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Overweight
Behavioral Symptoms
Mood Disorders
Mental Disorders
Body Weight
Signs and Symptoms
Naltrexone
Bupropion
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014