Binge-Eating Disorder
Conditions
Brief summary
The purpose of this study is to determine whether methylphenidate is effective in the treatment of binge eating disorder, in a randomized controlled trial extended release methylphenidate versus cognitive behavioral therapy for binge eating disorder in overweight or obese adult females.
Detailed description
Fifty-six adult female outpatients with binge eating disorder will receive 12 weeks of methylphenidate (dosage 18-72 mg) or 12 sessions of manualized cognitive behavioral therapy. Participants will complete interviewer-rated and self-report measures of eating, mood, attention, and personality features before treatment, after 6 weeks of treatment, immediately after treatment is completed, and 3 months after treatment is completed.
Interventions
DRUGMethylphenidate
* Weekly appointments with study psychiatrists for the first four weeks, and then biweekly appointments for the last eight weeks. * Intervention will consist of medication as well as components of Med-Plus treatment (e.g., medication management, general support, and compliance enhancement strategies).
BEHAVIORALCognitive Behavioral Therapy
Cognitive Behavior Therapy will include three phases: * Phase 1 undertakes to eliminate binge episodes and introduce a 'regular' pattern of eating; * Phase 2 aims to reduce food intake and restructure eating-related cognitions; * Phase 3 focuses upon relapse prevention
Sponsors
Ontario Mental Health Foundation
Centre for Addiction and Mental Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Binge-Eating Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition * Body Mass Index ≥ 25 * Must be fluent in English * Must be capable to give informed consent
Exclusion criteria
* Current pregnancy or lactation * Psychotherapy or behavioural treatment for eating or weight initiated during the past month * Psychotropic or investigational medications initiated / changed during the past three months * Concomitant use of another psychostimulant * Current mental disorders that are acute/unstable, that require alternate treatment, and/or that preclude ability to complete research protocol including mania, psychosis, substance use (alcohol or drugs), dementia, organic brain disorders, mental retardation * Current severe suicidality or homicidality * Current uncontrolled medical conditions that affect weight or BED symptoms or that are contraindicated for methylphenidate including metabolic, neurological, hepatic, renal, cardiovascular, hematological, ophthalmic, or endocrine diseases * Other serious medical illness or event such as acute myocardial infarction or stroke during the past six months * History of seizures or tics in the past year * Diagnosis or family history of Tourette's * Clinically relevant laboratory results, including: Tachycardia as indicated by heart rate \> 110; Hypertension as indicated by blood pressure parameters \> 140 (systolic) and 90 (diastolic); Arrhythmias or conduction abnormalities as indicated by ECG parameters QTC\> 460msec, QRS\>120 msec, and PR\>200 msec; Abnormal laboratory results (e.g., hypokalemia) as indicated by values \> 20% above the upper range of the laboratory standard of a basic metabolic screen * Current medications that affect weight * Current medications that are contraindicated for methylphenidate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of binge episodes/days, as assessed by prospective daily binge diary | After 12 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of objective binge episodes and overall illness severity, as assessed by both the Eating Disorder Examination Interview and Questionnaire | After 12 weeks of treatment |
| Clinician impression of illness severity and improvement, as assessed by the Clinical Global Impression scale | After 12 weeks of treatment |
| Quality of life, as assessed by the Quality of Life Inventory | After 12 weeks of treatment |
| Associated features of binge eating as captured by the Dutch Eating Behavior Questionnaire and Binge Eating Scale | After 12 weeks of treatment |
| Body Mass Index | After 12 weeks of treatment |
Countries
Canada
Outcome results
None listed