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

NCT ID: NCT00607789

Last Updated: 2017-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2009-10-31

Brief 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).

Detailed 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.

Conditions

Binge Eating; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Duloxetine Group

Start with 30 mg duloxetine hydrochloride capsule/day to be increased up to 120 mg per day.

Group Type: EXPERIMENTAL

Duloxetine

Intervention Type: DRUG

30 mg/day - 120 mg/day

Placebo Group

Sugar pill with matching dosage as Duloxetine

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

identical to study drug

Interventions

Duloxetine

30 mg/day - 120 mg/day

Intervention Type: DRUG

Placebo

identical to study drug

Intervention Type: DRUG

Other Intervention Names

Cymbalta; Sugar pill

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Erik Nelson

Erik B. Nelson, MD & Susan McElroy, University of Cincinnati & Lindner Center of HOPE

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erik B Nelson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University of Cincinnati and Lindner Center of HOPE

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

Nelson #2

Identifier Type: -

Identifier Source: org_study_id