NCT00414167

Brief Summary

This research study is designed to look at the effectiveness of bupropion for reducing binge eating in overweight persons with binge eating problems. Participants in the study will receive either bupropion or placebo ("sugar" pill, inactive medication) as an outpatient for eight weeks. In addition, participants will be given the option to receive 8 weeks of free behavioral weight loss treatment. This treatment, known to be effective for reducing binge eating and helping people lose weight, will be administered following the medication phase and at no cost. It is expected that compared to placebo, bupropion will produce greater reductions in binge eating.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2005

Longer than P75 for phase_2

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

December 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2006

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

March 28, 2014

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

5.2 years

First QC Date

December 20, 2006

Results QC Date

October 22, 2012

Last Update Submit

April 1, 2020

Conditions

Binge Eating DisorderObesity

Keywords

Binge eatingObesityMedicationCravingEmotional eating

Outcome Measures

Primary Outcomes (1)

  • Frequency of Binge Eating Episodes

    One week (at post treatment)

Secondary Outcomes (1)

  • Percent BMI Loss

    8 weeks (baseline and 8 weeks)

Study Arms (2)

1

EXPERIMENTAL

Bupropion

Drug: bupropion

2

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

bupropionDRUG

300 mg per day for 8 weeks

Also known as: wellbutrin, zyban
1
PlaceboOTHER

Placebo

2

Eligibility Criteria

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

You may qualify if:

  • BMI 25-50
  • Able to travel to clinical site (New Haven, CT) for bi-weekly visits.

You may not qualify if:

  • Predisposition to seizures
  • History of anorexia or bulimia nervosa
  • Current Type I or Type II diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

  • White MA, Grilo CM. Bupropion for overweight women with binge-eating disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2013 Apr;74(4):400-6. doi: 10.4088/JCP.12m08071.

    PMID: 23656848DERIVED

MeSH Terms

Conditions

Binge-Eating DisorderObesityBulimiaEmotional Eating

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperphagiaSigns and Symptoms, DigestiveFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Results Point of Contact

Title
Dr. Marney A. White
Organization
Yale University School of Medicine
marney.white@yale.edu
203-785-4349

Study Officials

  • Marney A. White, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2006

First Posted

December 21, 2006

Study Start

December 1, 2005

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

April 3, 2020

Results First Posted

March 28, 2014

Record last verified: 2020-04

Locations

US(1)