Clinical trial NCT00607789: Study of Duloxetine vs Placebo in Treatment of Binge Eating Disorder With Depression
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Binge Eating
Depression
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2008-02-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Binge Eating Days
timeFrame: 12 weeks
Secondary outcomes:
measure: Weekly Episodes
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati and Lindner Center of HOPE
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Erik B Nelson, MD
role: PRINCIPAL_INVESTIGATOR
References: