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

Primary Purpose

Binge-Eating Disorder

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Methylphenidate
Cognitive Behavioral Therapy
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge-Eating Disorder

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Methylphenidate

Cognitive Behavioral Therapy

Arm 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

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

Outcomes

Primary Outcome Measures

Frequency of binge episodes/days, as assessed by prospective daily binge diary

Secondary Outcome Measures

Frequency of objective binge episodes and overall illness severity, as assessed by both the Eating Disorder Examination Interview and Questionnaire
Clinician impression of illness severity and improvement, as assessed by the Clinical Global Impression scale
Quality of life, as assessed by the Quality of Life Inventory
Associated features of binge eating as captured by the Dutch Eating Behavior Questionnaire and Binge Eating Scale
Body Mass Index

Full Information

First Posted
August 7, 2013
Last Updated
February 3, 2017
Sponsor
Centre for Addiction and Mental Health
Collaborators
Ontario Mental Health Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01921582
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Ontario Mental Health Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge-Eating Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylphenidate
Arm Type
Experimental
Arm 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
Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
Cognitive Behavioral Therapy 12 individual 50-minute appointments over the course of up to 14 weeks According to Fairburn, Marcus, and Wilson (1993)
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Other Intervention Name(s)
TEVA-METHYLPHENIDATE ER-C
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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 Measure Information:
Title
Frequency of binge episodes/days, as assessed by prospective daily binge diary
Time Frame
After 12 weeks of treatment
Secondary Outcome Measure Information:
Title
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
Title
Clinician impression of illness severity and improvement, as assessed by the Clinical Global Impression scale
Time Frame
After 12 weeks of treatment
Title
Quality of life, as assessed by the Quality of Life Inventory
Time Frame
After 12 weeks of treatment
Title
Associated features of binge eating as captured by the Dutch Eating Behavior Questionnaire and Binge Eating Scale
Time Frame
After 12 weeks of treatment
Title
Body Mass Index
Time Frame
After 12 weeks of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena C Quilty, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Allan S Kaplan, MD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.camh.ca/research
Description
Information about research at the Centre for Addiction and Mental Health

Learn more about this trial

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

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