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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01921582
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : February 6, 2017
Ontario Mental Health Foundation
Information provided by (Responsible Party):
Lena Quilty, 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.

Condition or disease Intervention/treatment Phase
Binge-Eating Disorder Drug: Methylphenidate Behavioral: Cognitive Behavioral Therapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Methylphenidate


  • 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
Drug: Methylphenidate
  • Weekly 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).

Active Comparator: 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)
Behavioral: Cognitive Behavioral Therapy

Cognitive 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

Primary Outcome Measures :
  1. Frequency of binge episodes/days, as assessed by prospective daily binge diary [ Time Frame: After 12 weeks of treatment ]

Secondary Outcome Measures :
  1. Frequency of objective binge episodes and overall illness severity, as assessed by both the Eating Disorder Examination Interview and Questionnaire [ Time Frame: After 12 weeks of treatment ]
  2. Clinician impression of illness severity and improvement, as assessed by the Clinical Global Impression scale [ Time Frame: After 12 weeks of treatment ]
  3. Quality of life, as assessed by the Quality of Life Inventory [ Time Frame: After 12 weeks of treatment ]
  4. Associated features of binge eating as captured by the Dutch Eating Behavior Questionnaire and Binge Eating Scale [ Time Frame: After 12 weeks of treatment ]
  5. Body Mass Index [ Time Frame: After 12 weeks of treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01921582

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Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Centre for Addiction and Mental Health
Ontario Mental Health Foundation
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Principal Investigator: Lena C Quilty, PhD Centre for Addiction and Mental Health
Principal Investigator: Allan S Kaplan, MD Centre for Addiction and Mental Health
Additional Information:
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Responsible Party: Lena Quilty, Independent Scientist, Centre for Addiction and Mental Health Identifier: NCT01921582    
Other Study ID Numbers: 044/2013
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Feeding and Eating Disorders
Binge-Eating Disorder
Mental Disorders
Signs and Symptoms, Digestive
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents