Binge Eating, Depression
Conditions
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.
Interventions
DRUGDuloxetine
30 mg/day - 120 mg/day
DRUGPlacebo
identical to study drug
Sponsors
Eli Lilly and Company
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binge Eating Days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weekly Episodes | 12 weeks | The weekly frequency of binge episodes after baseline (number of binge eating days during the 12-week period divided by 7) |
Countries
United States
Participant flow
Recruitment details
All participants were recruited at the Lindner Center of HOPE location.
Pre-assignment details
64 participants were consented. 24 were not randomised: 21 did not meet entry criteria and 3 withdrew consent.
Participants by arm
| Arm | Count |
|---|---|
| Duloxetine Group Participants were randomized to 30-120 mg/day of duloxetine for 12 weeks | 20 |
| Placebo Group Participants who were randomized to 30-120 mg/day of sugar pill for 12 weeks | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Inadequate adherence | 3 | 0 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 5 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Duloxetine Group | Placebo Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Age, Continuous | 44.4 years STANDARD_DEVIATION 12.1 | 35.7 years STANDARD_DEVIATION 10.4 | 40.05 years STANDARD_DEVIATION 11.25 |
| Sex: Female, Male Female | 16 Participants | 19 Participants | 35 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 20 | 8 / 20 |
| serious Total, serious adverse events | 1 / 20 | 0 / 20 |
Outcome results
Primary
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).
Time frame: 12 weeks
Population: The primary efficacy analysis was a longitudinal analysis comparing the rate of change of binge day frequency during the treatment period between groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine Group | Binge Eating Days | 4.3 Mean Number of days | Standard Deviation 1.7 |
| Placebo Group | Binge Eating Days | 3.8 Mean Number of days | Standard Deviation 1.7 |
Comparison: The primary efficacy analysis was a longitudinal analysis comparing the rate of change of binge day frequency during the treatment period between groups. The same analysis was applied to binge episode frequency, weight, BMI, and scores on the CGI-Severity, YBOCS-BE, and IDS scales. The difference in rate of change was estimated by random regression methodsp-value: <0.05t-test, 2 sided
Secondary
Weekly Episodes
The weekly frequency of binge episodes after baseline (number of binge eating days during the 12-week period divided by 7)
Time frame: 12 weeks
Population: The secondary efficacy analysis was a longitudinal analysis comparing the rate of change of binge weeks frequency during the treatment period between groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine Group | Weekly Episodes | 4.7 Days | Standard Deviation 1.9 |
| Placebo Group | Weekly Episodes | 4.2 Days | Standard Deviation 2.6 |