Trial Outcomes & Findings for Study of Duloxetine vs Placebo in Treatment of Binge Eating Disorder With Depression (NCT NCT00607789)

NCT ID: NCT00607789

Last Updated: 2017-08-21

Results Overview

The mean number of binge days (days when the participant had one or more binge eating episodes) per week in the interval between visits (total number of binge days in the interval divided by number of days in the interval, then multiplied by 7).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2017-08-21

Participant Flow

All participants were recruited at the Lindner Center of HOPE location.

64 participants were consented. 24 were not randomised: 21 did not meet entry criteria and 3 withdrew consent.

Participant milestones

Measure	Duloxetine Group 30-120 mg/day of duloxetine during a 12-week period	Placebo Group Placebo tablets (identical to duloxetine tablets), 30-120 mg/d given over 12-week period
Overall Study STARTED	20	20
Overall Study COMPLETED	13	14
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Measure	Duloxetine Group 30-120 mg/day of duloxetine during a 12-week period	Placebo Group Placebo tablets (identical to duloxetine tablets), 30-120 mg/d given over 12-week period
Overall Study Adverse Event	3	0
Overall Study Lack of Efficacy	0	1
Overall Study Inadequate adherence	3	0
Overall Study Lost to Follow-up	0	5
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Study of Duloxetine vs Placebo in Treatment of Binge Eating Disorder With Depression

Baseline characteristics by cohort

Measure	Duloxetine Group n=20 Participants Participants were randomized to 30-120 mg/day of duloxetine for 12 weeks	Placebo Group n=20 Participants Participants who were randomized to 30-120 mg/day of sugar pill for 12 weeks	Total n=40 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	20 Participants n=5 Participants	20 Participants n=7 Participants	40 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	44.4 years STANDARD_DEVIATION 12.1 • n=5 Participants	35.7 years STANDARD_DEVIATION 10.4 • n=7 Participants	40.05 years STANDARD_DEVIATION 11.25 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: The primary efficacy analysis was a longitudinal analysis comparing the rate of change of binge day frequency during the treatment period between groups.

The mean number of binge days (days when the participant had one or more binge eating episodes) per week in the interval between visits (total number of binge days in the interval divided by number of days in the interval, then multiplied by 7).

Outcome measures

Measure	Duloxetine Group n=20 Participants Participants randomized to 30-120 mg/day of duloxetine for 12 weeks	Placebo Group n=20 Participants Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
Binge Eating Days	4.3 Mean Number of days Standard Deviation 1.7	3.8 Mean Number of days Standard Deviation 1.7

SECONDARY outcome

Timeframe: 12 weeks

Population: The secondary efficacy analysis was a longitudinal analysis comparing the rate of change of binge weeks frequency during the treatment period between groups.

The weekly frequency of binge episodes after baseline (number of binge eating days during the 12-week period divided by 7)

Outcome measures

Measure	Duloxetine Group n=20 Participants Participants randomized to 30-120 mg/day of duloxetine for 12 weeks	Placebo Group n=20 Participants Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
Weekly Episodes	4.7 Days Standard Deviation 1.9	4.2 Days Standard Deviation 2.6

Adverse Events

Duloxetine Group

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Duloxetine Group n=20 participants at risk Participants randomized to 30-120 mg/day of duloxetine for 12 weeks.	Placebo Group n=20 participants at risk Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
Gastrointestinal disorders Gastrointestinal problems	5.0% 1/20 • Number of events 1 • 12 weeks The most frequent adverse events were: constipation, dry mouth, hyperhydrosis, and nausea.	0.00% 0/20 • 12 weeks The most frequent adverse events were: constipation, dry mouth, hyperhydrosis, and nausea.
Respiratory, thoracic and mediastinal disorders Sinus Infection	5.0% 1/20 • Number of events 1 • 12 weeks The most frequent adverse events were: constipation, dry mouth, hyperhydrosis, and nausea.	0.00% 0/20 • 12 weeks The most frequent adverse events were: constipation, dry mouth, hyperhydrosis, and nausea.

Other adverse events

Measure	Duloxetine Group n=20 participants at risk Participants randomized to 30-120 mg/day of duloxetine for 12 weeks.	Placebo Group n=20 participants at risk Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
Gastrointestinal disorders Nausea	45.0% 9/20 • Number of events 9 • 12 weeks The most frequent adverse events were: constipation, dry mouth, hyperhydrosis, and nausea.	15.0% 3/20 • Number of events 3 • 12 weeks The most frequent adverse events were: constipation, dry mouth, hyperhydrosis, and nausea.
General disorders Dry Mouth	35.0% 7/20 • Number of events 7 • 12 weeks The most frequent adverse events were: constipation, dry mouth, hyperhydrosis, and nausea.	10.0% 2/20 • Number of events 2 • 12 weeks The most frequent adverse events were: constipation, dry mouth, hyperhydrosis, and nausea.
Gastrointestinal disorders Constipation	25.0% 5/20 • Number of events 5 • 12 weeks The most frequent adverse events were: constipation, dry mouth, hyperhydrosis, and nausea.	5.0% 1/20 • Number of events 1 • 12 weeks The most frequent adverse events were: constipation, dry mouth, hyperhydrosis, and nausea.
Endocrine disorders Hyperhydrosis	25.0% 5/20 • Number of events 5 • 12 weeks The most frequent adverse events were: constipation, dry mouth, hyperhydrosis, and nausea.	10.0% 2/20 • Number of events 2 • 12 weeks The most frequent adverse events were: constipation, dry mouth, hyperhydrosis, and nausea.

Additional Information

Susan McElroy, MD

Lindner Center of HOPE

Phone: 513-536-0718

Email: susan.mcelroy@lindnercenter.org

Results disclosure agreements

• Principal investigator is a sponsor employee All trial data will be posted \& published by the Lindner Center of HOPE (PI: Dr. Susan McElroy)
• Publication restrictions are in place

Restriction type: OTHER