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

Binge-Eating Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921582
• Other study ID #: 044/2013
• Status: Completed
• Phase: Phase 2
• First received: August 7, 2013
• Last updated: February 3, 2017
• Start date: August 2013
• Est. completion date: September 2015

Study information

• Verified date: February 2017
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Disease
• Feeding and Eating Disorders

Intervention

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).

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

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Ontario Mental Health Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of binge episodes/days, as assessed by prospective daily binge diary		After 12 weeks of treatment
Secondary	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
Secondary	Clinician impression of illness severity and improvement, as assessed by the Clinical Global Impression scale		After 12 weeks of treatment
Secondary	Quality of life, as assessed by the Quality of Life Inventory		After 12 weeks of treatment
Secondary	Associated features of binge eating as captured by the Dutch Eating Behavior Questionnaire and Binge Eating Scale		After 12 weeks of treatment
Secondary	Body Mass Index		After 12 weeks of treatment

External Links

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