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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Centre for Addiction and Mental Health
Sponsor:
Collaborator:
Ontario Mental Health Foundation
Information provided by (Responsible Party):
Lena Quilty, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01921582
First received: August 7, 2013
Last updated: October 3, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Binge-Eating Disorder
Drug: Methylphenidate
Behavioral: Cognitive Behavioral Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Frequency of binge episodes/days, as assessed by prospective daily binge diary [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Clinician impression of illness severity and improvement, as assessed by the Clinical Global Impression scale [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Quality of life, as assessed by the Quality of Life Inventory [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Associated features of binge eating as captured by the Dutch Eating Behavior Questionnaire and Binge Eating Scale [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Body Mass Index [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: August 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01921582

Contacts
Contact: Lena C Quilty, PhD 416-535-8501 ext 34313 lena.quilty@camh.ca
Contact: Daniela Avila Murati, HBSc 416-535-8501 ext 36891 daniela.avila@camh.ca

Locations
Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M5T 1R8
Contact: Lena C Quilty, PhD    416-535-8501 ext 34313    lena.quilty@camh.ca   
Principal Investigator: Lena C Quilty, PhD         
Principal Investigator: Allan S Kaplan, MD         
Sponsors and Collaborators
Centre for Addiction and Mental Health
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
  More Information

Additional Information:
No publications provided

Responsible Party: Lena Quilty, Independent Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01921582     History of Changes
Other Study ID Numbers: 044/2013
Study First Received: August 7, 2013
Last Updated: October 3, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Binge-Eating Disorder
Eating Disorders
Bulimia
Disease
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Pathologic Processes
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014