Trial Outcomes & Findings for Craving, Binge Eating and Obesity (NCT NCT00414167)

NCT ID: NCT00414167

Last Updated: 2020-04-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 61 participants
• Primary outcome timeframe: One week (at post treatment)
• Results posted on: 2020-04-03

Participant Flow

Sixty-one overweight and obese women with BED were recruited from the community via advertisements. Participants were enrolled from November 2006 to December 2010. Assessments and clinic appointments were held in a medical school research clinic.

Participant milestones

Measure	Bupropion (300 mg/d) Bupropion bupropion : 300 mg per day for 8 weeks	Placebo Placebo Placebo : Placebo
Overall Study STARTED	31	30
Overall Study COMPLETED	27	27
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Craving, Binge Eating and Obesity

Baseline characteristics by cohort

Measure	Bupropion n=31 Participants Bupropion bupropion : 300 mg per day for 8 weeks	Placebo n=30 Participants Placebo Placebo : Placebo	Total n=61 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	30 Participants n=7 Participants	61 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	45.2 years STANDARD_DEVIATION 12.1 • n=5 Participants	43.1 years STANDARD_DEVIATION 13.0 • n=7 Participants	44.2 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	30 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: One week (at post treatment)

Population: Baseline forward imputation for missing data.

Outcome measures

Measure	Bupropion n=31 Participants	Placebo n=30 Participants
Frequency of Binge Eating Episodes	0.8 episodes/week Standard Deviation 1.2	1.0 episodes/week Standard Deviation 1.5

SECONDARY outcome

Timeframe: 8 weeks (baseline and 8 weeks)

Population: Baseline values imputed forward for missing data.

Percent loss in Body Mass Index

Outcome measures

Measure	Bupropion n=31 Participants	Placebo n=20 Participants
Percent BMI Loss	1.8 Percent loss Standard Deviation 2.6	0.6 Percent loss Standard Deviation 2.1

Adverse Events

Bupropion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Marney A. White

Yale University School of Medicine

Phone: 203-785-4349

Email: marney.white@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place