NCT00624858

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2 depression

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_2 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 27, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

October 30, 2012

Status Verified

October 1, 2012

Enrollment Period

1.5 years

First QC Date

February 19, 2008

Last Update Submit

October 23, 2012

Conditions

Depression

Keywords

Depressiondepressedoverweightobese

Outcome Measures

Primary Outcomes (1)

  • To assess the change in depressive symptoms as measured by Montgomery-Asberg Depression Rating Scale (MADRS) total score at 12 weeks

    12 Weeks

Secondary Outcomes (1)

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

    12 and 24 weeks

Study Arms (1)

NB32

EXPERIMENTAL

Naltrexone SR 32 mg/Bupropion SR 360 mg/ day

Drug: naltrexone SR 32 mg/ bupropion SR 360 mg daily

Interventions

naltrexone SR 32 mg/ bupropion SR 360 mg dailyDRUG

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

NB32

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lindner Center of HOPE

Mason, Ohio, 45040, United States

Location

Related Publications (1)

  • McElroy SL, Guerdjikova AI, Kim DD, Burns C, Harris-Collazo R, Landbloom R, Dunayevich E. Naltrexone/Bupropion combination therapy in overweight or obese patients with major depressive disorder: results of a pilot study. Prim Care Companion CNS Disord. 2013;15(3):PCC.12m01494. doi: 10.4088/PCC.12m01494. Epub 2013 Jun 20.

    PMID: 24171147DERIVED

MeSH Terms

Conditions

DepressionConsciousness DisordersOverweightObesity

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • Susan McElroy, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2008

First Posted

February 27, 2008

Study Start

January 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

October 30, 2012

Record last verified: 2012-10

Locations

US(1)