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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624858
• Other study ID #: NB-402
• Status: Completed
• Phase: Phase 2
• First received: February 19, 2008
• Last updated: October 23, 2012
• Start date: January 2008
• Est. completion date: July 2009

Study information

• Verified date: October 2012
• Source: Orexigen Therapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Overweight

Intervention

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

Locations

Country	Name	City	State
United States	Lindner Center of HOPE	Mason	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Orexigen Therapeutics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the change in depressive symptoms as measured by Montgomery-Asberg Depression Rating Scale (MADRS) total score at 12 weeks		12 Weeks	No
Secondary	To assess the percentage change from baseline in total body weight at 12 and 24 weeks.		12 and 24 weeks	No