Trial Outcomes & Findings for Treatment of Binge Eating in Obese Patients in Primary Care (NCT NCT00537810)

NCT ID: NCT00537810

Last Updated: 2021-08-18

Results Overview

Remission from binge eating (zero binge episodes during previous 28 days)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 104 participants
• Primary outcome timeframe: 4 months treatment; 6 and 12 month follow up post treatment
• Results posted on: 2021-08-18

Participant Flow

Participant milestones

Measure	Sibutramine Sibutramine 15 mg daily Sibutramine: 15 mg daily	Placebo Placebo Daily Placebo: Daily	Placebo/CBTsh Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily	Sibutramine/CBTsh Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily
Overall Study STARTED	26	27	25	26
Overall Study COMPLETED	20	14	21	22
Overall Study NOT COMPLETED	6	13	4	4

Reasons for withdrawal

Measure	Sibutramine Sibutramine 15 mg daily Sibutramine: 15 mg daily	Placebo Placebo Daily Placebo: Daily	Placebo/CBTsh Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily	Sibutramine/CBTsh Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily
Overall Study Withdrawal by Subject	4	11	4	3
Overall Study Medically withdrawn	2	2	0	1

Baseline Characteristics

Treatment of Binge Eating in Obese Patients in Primary Care

Baseline characteristics by cohort

Measure	Sibutramine n=26 Participants Sibutramine 15 mg daily Sibutramine: 15 mg daily	Placebo n=27 Participants Placebo Daily Placebo: Daily	Placebo/CBTsh n=25 Participants Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily	Sibutramine/CBTsh n=26 Participants Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily	Total n=104 Participants Total of all reporting groups
Age, Continuous	41.2 years STANDARD_DEVIATION 10.3 • n=5 Participants	43.2 years STANDARD_DEVIATION 12.4 • n=7 Participants	45.7 years STANDARD_DEVIATION 12.4 • n=5 Participants	45.6 years STANDARD_DEVIATION 9.4 • n=4 Participants	44.2 years STANDARD_DEVIATION 11.1 • n=21 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	18 Participants n=7 Participants	20 Participants n=5 Participants	16 Participants n=4 Participants	73 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants	31 Participants n=21 Participants
Race/Ethnicity, Customized Caucasian	13 participants n=5 Participants	12 participants n=7 Participants	12 participants n=5 Participants	10 participants n=4 Participants	47 participants n=21 Participants
Race/Ethnicity, Customized African-American	8 participants n=5 Participants	12 participants n=7 Participants	6 participants n=5 Participants	10 participants n=4 Participants	36 participants n=21 Participants
Race/Ethnicity, Customized Hispanic-American	4 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants	4 participants n=4 Participants	14 participants n=21 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants	2 participants n=4 Participants	7 participants n=21 Participants
Age at onset of Binge Eating Disorder (BED)	25.7 years STANDARD_DEVIATION 11.2 • n=5 Participants	25.5 years STANDARD_DEVIATION 11.1 • n=7 Participants	25.7 years STANDARD_DEVIATION 15.1 • n=5 Participants	29.1 years STANDARD_DEVIATION 13.1 • n=4 Participants	26.2 years STANDARD_DEVIATION 12.5 • n=21 Participants

PRIMARY outcome

Timeframe: 4 months treatment; 6 and 12 month follow up post treatment

Remission from binge eating (zero binge episodes during previous 28 days)

Outcome measures

Measure	Sibutramine n=26 Participants Sibutramine 15 mg daily Sibutramine: 15 mg daily	Placebo n=27 Participants Placebo Daily Placebo: Daily	Placebo/CBTsh n=25 Participants Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily	Sibutramine/CBTsh n=26 Participants Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily
Binge Eating (Remission) Remission at Post-treatment	10 participants 11.4	8 participants 9.9	6 participants 7.6	6 participants 8.0
Binge Eating (Remission) Remission at 6 month follow up	5 participants	11 participants	10 participants	13 participants
Binge Eating (Remission) Remission at 12 month follow up	5 participants	10 participants	10 participants	11 participants

PRIMARY outcome

Timeframe: 4 months

Population: Participants with complete data reported here (i.e., no imputation)

BMI (kg/m^2) was measured 4 months after treatment.

Outcome measures

Measure	Sibutramine n=21 Participants Sibutramine 15 mg daily Sibutramine: 15 mg daily	Placebo n=19 Participants Placebo Daily Placebo: Daily	Placebo/CBTsh n=22 Participants Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily	Sibutramine/CBTsh n=22 Participants Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily
BMI	38.4 BMI (kg/m^2) Standard Deviation 7.2	39.6 BMI (kg/m^2) Standard Deviation 5.7	35.9 BMI (kg/m^2) Standard Deviation 5.6	35.6 BMI (kg/m^2) Standard Deviation 4.6

Adverse Events

Sibutramine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo/CBTsh

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sibutramine/CBTsh

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sibutramine n=26 participants at risk Sibutramine 15 mg daily Sibutramine: 15 mg daily	Placebo n=27 participants at risk Placebo Daily Placebo: Daily	Placebo/CBTsh n=25 participants at risk Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily	Sibutramine/CBTsh n=26 participants at risk Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily
Vascular disorders Elevated blood pressure	3.8% 1/26	7.4% 2/27	0.00% 0/25	3.8% 1/26

Additional Information

Dr. Carlos Grilo

Yale University School of Medicine

Phone: 2037852792

Email: carlos.grilo@yale.edu

Results disclosure agreements

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