Status:
COMPLETED
A Comparison of Methylphenidate and Cognitive Behavioural Therapy for the Treatment of Binge Eating Disorder
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
Ontario Mental Health Foundation
Conditions:
Binge-Eating Disorder
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
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 cogni...
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01921582
Start Date
August 1 2013
End Date
September 1 2015
Last Update
February 6 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8