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

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre for Addiction and Mental Health
• Collaborator: Ontario Mental Health Foundation
• Treatments: Methylphenidate

Criteria

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