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

Information source: Centre for Addiction and Mental Health
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Binge-Eating Disorder

Intervention: Methylphenidate (Drug); Cognitive Behavioral Therapy (Behavioral)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Centre for Addiction and Mental Health

Official(s) and/or principal investigator(s):
Lena C Quilty, PhD, Principal Investigator, Affiliation: Centre for Addiction and Mental Health
Allan S Kaplan, MD, Principal Investigator, Affiliation: Centre for Addiction and Mental Health

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome:

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

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

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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

Locations and Contacts

Centre for Addiction and Mental Health, Toronto, Ontario M5T 1R8, Canada
Additional Information

Information about research at the Centre for Addiction and Mental Health

Starting date: August 2013
Last updated: May 4, 2015

Page last updated: August 23, 2015

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