The purpose of this research study is to test the safety of duloxetine and see what effects (good and bad) it has on the subject's binge eating disorder and comorbid depressive disorder (depression occurring with binge eating disorder) compared to placebo (inactive pill).
This is a 12-week, double blind, randomized, placebo-controlled, parallel-group, flexible-dose study of duloxetine 60-120 mg/day in patients with BED and comorbid depressive disorders. Patients will be randomly assigned to either duloxetine 30 mg capsules or matching placebo at the baseline visit. The initial dose of study medication will be one 30 mg duloxetine capsule/day or placebo with a planned increase to 60 mg/day (2 X 30 mg) or matching placebo at the end of week 1. Further dose increases of 30 mg up to 120 mg/day will be allowed after the end of week two based on the investigators' assessment of efficacy and tolerability. Dosing will be either once per day or twice a day depending on tolerability. Patient visits will occur at screening and baseline and at the end of weeks 1, 2, 4, 6, 8, 10, and 12. Study drug will be tapered by 30 mg every 3 days at the end of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
30 mg/day - 120 mg/day
identical to study drug
University of Cincinnati and Lindner Center of HOPE
Cincinnati, Ohio, United States
Binge Eating Days
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).
Time frame: 12 weeks
Weekly Episodes
The weekly frequency of binge episodes after baseline (number of binge eating days during the 12-week period divided by 7)
Time frame: 12 weeks
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