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

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