A Comparison of Methylphenidate and Cognitive Behavioural Therapy for the Treatment of Binge Eating Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Comparison of Osmotic Release Oral System Methylphenidate and Cognitive Behavioural Therapy for the Treatment of Obese Patients With Binge Eating Disorder

Conditions
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Binge-Eating Disorder

Intervention / Treatment
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* Drug: Methylphenidate
* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylphenidate<br>Methylphenidate (TEVA-METHYLPHENIDATE ER-C) Dosage: 18 mg/day at Week 1; 36 mg/day at Week 2; 54 mg/day at Week 3; 72 mg/day at Week 4. Dosage levels may be maintained or decreased to manage medication side effects. Dosage form: tablet Dosage frequency: daily Duration: 12 weeks total | Drug: Methylphenidate<br>* 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).<br>* Other names: TEVA-METHYLPHENIDATE ER-C;|
| Active Comparator: Cognitive Behavioral Therapy<br>Cognitive Behavioral Therapy 12 individual 50-minute appointments over the course of up to 14 weeks According to Fairburn, Marcus, and Wilson (1993) | Behavioral: Cognitive Behavioral Therapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of binge episodes/days, as assessed by prospective daily binge diary |  | After 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |