Study of Duloxetine vs Placebo in Treatment of Binge Eating Disorder With Depression
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A 12-Week, Double-Blind, Placebo-Controlled, Trial of Duloxetine Versus Placebo in the Treatment of Binge Eating Disorder and Comorbid Depressive Disorder.|
- Binge Eating Days [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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).
- Weekly Episodes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The weekly frequency of binge episodes after baseline (number of binge eating days during the 12-week period divided by 7)
|Study Start Date:||October 2006|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Experimental: Duloxetine Group
Start with 30 mg duloxetine hydrochloride capsule/day to be increased up to 120 mg per day.
30 mg/day - 120 mg/day
Other Name: Cymbalta
Placebo Comparator: Placebo Group
Sugar pill with matching dosage as Duloxetine
identical to study drug
Other Name: Sugar 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.
|United States, Ohio|
|University of Cincinnati and Lindner Center of HOPE|
|Cincinnati, Ohio, United States, 45219|
|Principal Investigator:||Erik B Nelson, MD||University of Cincinnati|