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

Center for Addiction and Mental Health (CAMH)

Status and phase: Completed; Phase 2

Conditions: Binge-Eating Disorder

Treatments: Behavioral: Cognitive Behavioral Therapy; Drug: Methylphenidate

Study type: Interventional

Funder types: Other

Identifiers

NCT01921582

044/2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

51 participants in 2 patient groups

Methylphenidate

Experimental group

Description:

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

Treatment:

Drug: Methylphenidate

Cognitive Behavioral Therapy

Active Comparator group

Description:

Cognitive Behavioral Therapy * 12 individual 50-minute appointments over the course of up to 14 weeks * According to Fairburn, Marcus, and Wilson (1993)

Treatment:

Behavioral: Cognitive Behavioral Therapy