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

NCT00607789 | Completed Phase 4 Results DMC

• 1 other identifier: Nelson #2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Binge Eating; Depression

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Weekly Episodes

  12 weeks

Study Arms (2)

Duloxetine Group

EXPERIMENTAL

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

Drug: Duloxetine

Placebo Group

PLACEBO COMPARATOR

Sugar pill with matching dosage as Duloxetine

Drug: Placebo

Interventions

Duloxetine DRUG

30 mg/day - 120 mg/day

Also known as: Cymbalta

Duloxetine Group

Placebo DRUG

identical to study drug

Also known as: Sugar pill

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Recurrent episodes of binge eating.
• 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.
• Marked distress regarding binge eating.
• The binge eating occurs, on average, at least two days a week for the past six months.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

University of Cincinnati and Lindner Center of HOPE

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Bulimia; Depression

Interventions

Duloxetine Hydrochloride; Sugars

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Susan McElroy, MD
• Organization: Lindner Center of HOPE

susan.mcelroy@lindnercenter.org

513-536-0718

Study Officials

• Erik B Nelson, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Erik B. Nelson, MD & Susan McElroy, University of Cincinnati & Lindner Center of HOPE

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 6, 2008
• Study Start: October 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: August 21, 2017
• Results First Posted: November 14, 2012

Record last verified: 2012-09

Locations

US (1)