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Completed

NCT Number: NCT01921582

A Comparison of Methylphenidate and Cognitive Behavioural Therapy for the Treatment of 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.

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Key information

Conditions

Binge-Eating Disorder Feeding and Eating Disorders Mental Disorders

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylphenidate

Drug
  • 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

Cognitive behavioral therapy

Behavioral

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 outcomes

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

    Time frame: After 12 weeks of treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • Ontario Mental Health Foundation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 13, 2013
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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