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

NCT01921582 | Completed Phase 2

• 1 other identifier: 044/2013
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge-Eating Disorder

Outcome Measures

Primary Outcomes (1)

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

  After 12 weeks of treatment

Secondary Outcomes (5)

• Frequency of objective binge episodes and overall illness severity, as assessed by both the Eating Disorder Examination Interview and Questionnaire

  After 12 weeks of treatment

• Clinician impression of illness severity and improvement, as assessed by the Clinical Global Impression scale

  After 12 weeks of treatment

• Quality of life, as assessed by the Quality of Life Inventory

  After 12 weeks of treatment

• Associated features of binge eating as captured by the Dutch Eating Behavior Questionnaire and Binge Eating Scale

  After 12 weeks of treatment

• Body Mass Index

  After 12 weeks of treatment

Study Arms (2)

Methylphenidate

EXPERIMENTAL

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

Cognitive Behavioral Therapy

ACTIVE COMPARATOR

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

Interventions

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).

Also known as: TEVA-METHYLPHENIDATE ER-C

Methylphenidate

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

Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Ontario Mental Health Foundation: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Links

• Information about research at the Centre for Addiction and Mental Health

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

Methylphenidate; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lena C Quilty, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

• Allan S Kaplan, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Independent Scientist

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 13, 2013
• Study Start: August 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 6, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)