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

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

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.

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.

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