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 QuestionnaireClinician 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
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