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Completed

NCT Number: NCT00624858

A Study of Naltrexone SR/ Bupropion 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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Body Weight Consciousness Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lindner Center of HOPE

Mason, Ohio, 45040, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

naltrexone SR 32 mg/ bupropion SR 360 mg daily

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

Primary outcomes

  1. 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 outcomes

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

    Time frame: 12 and 24 weeks

Sponsors and collaborators

Lead sponsor

Orexigen Therapeutics, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 27, 2008
Registry last updated
Oct 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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