Clinical trial NCT01921582: A Comparison of Methylphenidate and Cognitive Behavioural Therapy for the Treatment of Binge Eating Disorder
Official title: A Randomized Comparison of Osmotic Release Oral System Methylphenidate and Cognitive Behavioural Therapy for the Treatment of Obese Patients With Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Binge-Eating Disorder
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Ontario Mental Health Foundation
First posted: 2013-08-13
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Frequency of binge episodes/days, as assessed by prospective daily binge diary
timeFrame: After 12 weeks of treatment
Secondary outcomes:
measure: Frequency of objective binge episodes and overall illness severity, as assessed by both the Eating Disorder Examination Interview and Questionnaire
timeFrame: After 12 weeks of treatment
measure: Clinician impression of illness severity and improvement, as assessed by the Clinical Global Impression scale
timeFrame: After 12 weeks of treatment
measure: Quality of life, as assessed by the Quality of Life Inventory
timeFrame: After 12 weeks of treatment
measure: Associated features of binge eating as captured by the Dutch Eating Behavior Questionnaire and Binge Eating Scale
timeFrame: After 12 weeks of treatment
measure: Body Mass Index
timeFrame: After 12 weeks of treatment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Lena C Quilty, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Addiction and Mental Health
name: Allan S Kaplan, MD
role: PRINCIPAL_INVESTIGATOR
References: