Binge-Eating Disorder | A Comparison of Methylphenidate and Cognitive Behavioural Therapy for the Treatment of Binge Eating Disorder
Binge-Eating Disorder research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:MethylphenidateWeekly 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).
Behavioral:Cognitive Behavioral TherapyCognitive 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
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
MethylphenidateMethylphenidate (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
Cognitive Behavioral TherapyCognitive Behavioral Therapy 12 individual 50-minute appointments over the course of up to 14 weeks According to Fairburn, Marcus, and Wilson (1993)
Start Date: August 2013
Completed Date: September 2015
Phase: Phase 2
Primary Outcome: Frequency of binge episodes/days, as assessed by prospective daily binge diary
Secondary Outcome: Frequency of objective binge episodes and overall illness severity, as assessed by both the Eating Disorder Examination Interview and Questionnaire
Study sponsors, principal investigator, and references
Principal Investigator: Lena C Quilty, PhD
Lead Sponsor: Centre for Addiction and Mental Health
Collaborator: Ontario Mental Health Foundation