Expired Study
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Mason, Ohio 45040


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.


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.


NCT ID:

NCT00624858


Primary Contact:

Principal Investigator
Susan McElroy, MD
University of Cincinnati


Backup Contact:

N/A


Location Contact:

Mason, Ohio 45040
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 19, 2018

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