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

Depression Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607789
• Other study ID #: Nelson #2
• Status: Completed
• Phase: Phase 4
• First received: January 23, 2008
• Last updated: October 12, 2012
• Start date: October 2006
• Est. completion date: October 2009

Study information

• Verified date: September 2012
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

• Subjects must provide written informed consent of their own free will.

• Male or female outpatients.

• Age 18-65 years, inclusive.

• Subject must meet the DSM-IV criteria for a diagnosis of a depressive disorder (major depression, dysthymia, minor depression, or brief recurrent depression) for a duration of at least 1 month preceding and during the screening period.

• Subjects must meet the DSM-IV criteria for a diagnosis of binge eating disorder (BED) for at least the last 6 months. The DSM-IV criteria are as follows:

1. Recurrent episodes of binge eating.

2. The binge eating episodes are associated with at least three of the following:

eating much more rapidly than normal; eating until uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of being embarrassed by how much one is eating; feeling disgusted with oneself, depressed, or feeling very guilty after overeating.

3. Marked distress regarding binge eating.

4. The binge eating occurs, on average, at least two days a week for the past six months.

5. The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa.

• Subjects will have an IDS score of at least 25 at the baseline visit.

Exclusion Criteria:

• Women who are pregnant, breastfeeding, or of childbearing potential who are not using a medically acceptable, effective method of birth control. Women of childbearing potential include all pre-menopausal women biologically capable of becoming pregnant or contributing a fertilizable ovum. Medically acceptable methods of birth control include oral contraceptives, an intrauterine device, use of two combined barrier methods, or surgical sterilization.

• Patients who display significant risk for suicide.

• Patients who have received psychotherapy or behavioral therapy from a mental health professional as a part of previous treatment for MDD or obesity for at least 3 months prior to randomization.

• A DSM-IV diagnosis of alcohol or substance abuse or dependence, bulimia nervosa, or anorexia nervosa within the 6 months prior to randomization.

• Patients with a lifetime DSM-IV history of a psychotic disorder, a bipolar disorder, or dementia.

• Patients with a history of psychosurgery

• Patients with an Axis II disorder (personality disorders such as schizotypal, borderline, or antisocial), which might interfere with a diagnostic assessment, treatment, or compliance.

• Patients with clinically unstable medical disease.

• Patients with hepatic insufficiency

• Patients with end-stage renal disease or severe renal impairment

• Patients with a history of seizures, including febrile seizures in childhood.

• Patients requiring treatment with any drug which might interact adversely with or obscure the action of the study medication.

• Patients with a known hypersensitivity to duloxetine or any of the inactive ingredients of duloxetine (Cymbalta).

• Patients with uncontrolled narrow-angle glaucoma.

• Patients with clinically relevant abnormal laboratory results, specifically including hypokalemia.

• Patients who have received monoamine oxidase inhibitors, tricyclics, antipsychotics, lithium, or fluoxetine within four weeks prior to randomization.

• Patients who have received other psychoactive medications (including appetite suppressants) or any anti-obesity medications within one week prior to randomization.

• Patients who have received investigational medications or depot neuroleptics within three months prior to randomization.

• Patients previously enrolled in this study or who have previously been treated with duloxetine.

• Subject considered by the investigator as unable to be followed up throughout the entire duration of the study.

• Patients taking medications that inhibit the P450-2D6 hepatic isoenzyme

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Binge Eating
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Depression
• Eating Disorders

Intervention

Drug:
• Duloxetine
30 mg/day - 120 mg/day
• Placebo
identical to study drug

Locations

Country	Name	City	State
United States	University of Cincinnati and Lindner Center of HOPE	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 weeks	No
Secondary	Weekly Episodes	The weekly frequency of binge episodes after baseline (number of binge eating days during the 12-week period divided by 7)	12 weeks	No