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

February 3, 2017 updated by: Lena Quilty, Centre for Addiction and Mental Health

A Randomized Comparison of Osmotic Release Oral System Methylphenidate and Cognitive Behavioural Therapy for the Treatment of Obese Patients With Binge Eating Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 1R8
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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).
Other Names:
  • TEVA-METHYLPHENIDATE ER-C
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of binge episodes/days, as assessed by prospective daily binge diary
Time Frame: After 12 weeks of treatment
After 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
After 12 weeks of treatment
Clinician impression of illness severity and improvement, as assessed by the Clinical Global Impression scale
Time Frame: After 12 weeks of treatment
After 12 weeks of treatment
Quality of life, as assessed by the Quality of Life Inventory
Time Frame: After 12 weeks of treatment
After 12 weeks of treatment
Associated features of binge eating as captured by the Dutch Eating Behavior Questionnaire and Binge Eating Scale
Time Frame: After 12 weeks of treatment
After 12 weeks of treatment
Body Mass Index
Time Frame: After 12 weeks of treatment
After 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Collaborators

Ontario Mental Health Foundation

Investigators

  • Principal Investigator: Lena C Quilty, PhD, Centre for Addiction and Mental Health
  • Principal Investigator: Allan S Kaplan, MD, Centre for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

August 7, 2013

First Submitted That Met QC Criteria

August 9, 2013

First Posted (Estimate)

August 13, 2013

Study Record Updates

Last Update Posted (Estimate)

February 6, 2017

Last Update Submitted That Met QC Criteria

February 3, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 044/2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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