- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00607789
Study of Duloxetine vs Placebo in Treatment of Binge Eating Disorder With Depression
July 20, 2017 updated by: Erik Nelson, University of Cincinnati
A 12-Week, Double-Blind, Placebo-Controlled, Trial of Duloxetine Versus Placebo in the Treatment of Binge Eating Disorder and Comorbid Depressive Disorder.
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
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Cincinnati, Ohio, United States, 45219
- University of Cincinnati and Lindner Center of HOPE
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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.
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 Names:
|
Placebo Comparator: Placebo Group
Sugar pill with matching dosage as Duloxetine
|
identical to study drug
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Binge Eating Days
Time Frame: 12 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weekly Episodes
Time Frame: 12 weeks
|
The weekly frequency of binge episodes after baseline (number of binge eating days during the 12-week period divided by 7)
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Erik B Nelson, MD, University of Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
January 23, 2008
First Submitted That Met QC Criteria
February 5, 2008
First Posted (Estimate)
February 6, 2008
Study Record Updates
Last Update Posted (Actual)
August 21, 2017
Last Update Submitted That Met QC Criteria
July 20, 2017
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Signs and Symptoms, Digestive
- Hyperphagia
- Depression
- Depressive Disorder
- Bulimia
- Feeding and Eating Disorders
- Binge-Eating Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Serotonin and Noradrenaline Reuptake Inhibitors
- Duloxetine Hydrochloride
Other Study ID Numbers
- Nelson #2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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