A Comparison of Methylphenidate and Cognitive Behavioural Therapy for the Treatment of Binge Eating Disorder
Phase 2
Completed
- Conditions
- Binge-Eating Disorder
- Interventions
- Behavioral: Cognitive Behavioral Therapy
- Registration Number
- NCT01921582
- Lead Sponsor
- Centre for Addiction and Mental Health
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 51
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive Behavioral Therapy Cognitive Behavioral Therapy Cognitive Behavioral Therapy * 12 individual 50-minute appointments over the course of up to 14 weeks * According to Fairburn, Marcus, and Wilson (1993) Methylphenidate Methylphenidate 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
- Primary Outcome Measures
Name Time Method Frequency of binge episodes/days, as assessed by prospective daily binge diary After 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method Quality of life, as assessed by the Quality of Life Inventory After 12 weeks of treatment 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 Associated features of binge eating as captured by the Dutch Eating Behavior Questionnaire and Binge Eating Scale 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 Body Mass Index After 12 weeks of treatment
Trial Locations
- Locations (1)
Centre for Addiction and Mental Health
🇨🇦Toronto, Ontario, Canada