The Effects of Methylphenidate on Energy Intake and Energy Expenditure
MPH
1 other identifier
interventional
40
1 country
2
Brief Summary
The Problem: Obesity is one of the leading causes of chronic disease and death. The efficacy of diet and exercise to sustain weight loss over the long term is weak. While pharmacotherapy is more effective than behavior intervention in maintaining weight loss the effects are often not sufficient to achieve optimal health benefits. Current drug treatments may be sub-optimal because they do not directly target the rewarding value of food, drive to eat, food liking, and impulsivity for eating energy dense snack foods, all of which influences both quantity and quality of food intake and impacts adherence needed to maintain weight loss. The Solution: The limitations in current anti-obesity agents are potentially addressed by Methylphenidate (MPH). We showed that MPH reduces food intake, dietary fat intake, hunger and food reward, as increase resting energy expenditure in obese and non-obese adults;however, no controlled field trials have been conducted in obese individuals without ADHD. Objectives/Hypotheses: Primary: To test the effects of MPH on energy intake in obese men and women. Secondary: to examine the effects of MPH on energy expenditure, body weight, impulsivity, food reward, and olfaction. The investigators predict that compared to placebo, MPH will show reduced appetite, along with reduced impulsivity, food reward, and smell function. Deliverable: This study may be the first to establish the short-term efficacy and safety of using MPH for weight loss, and if successful, data will inform a larger trial that can potentially identify MPH as a novel therapeutic agent for treating obesity and related chronic diseases in a predisposed population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 obesity
Started Jan 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2016
CompletedFirst Posted
Study publicly available on registry
April 28, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedAugust 3, 2017
August 1, 2017
1.6 years
April 12, 2016
August 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Energy Intake
Participant will be offered a lunch buffet that includes items they indicate are preferred. They will be able to eat as much or as little as they choose.
Measured three times over the course of 2 months (twice at baseline: once with and without study drug & once at final visit).
Secondary Outcomes (7)
Change in Energy Expenditure
Measured three times over the course of 2 months (twice at baseline: once with and without study drug & once at final visit).
Change in Body Weight
Measured two times over the course of 2 months (once at baseline & once at final visit).
Height
Measured at baseline.
Height
Measured at final visit; height will be used to determine BMI at the final visit.
Change in Body Mass Index
Measured two times over the course of 2 months (once at baseline & once at final visit).
- +2 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATOR60 day oral administration of sugar placebo twice per day before lunch and supper.
Methylphenidate (MPH)
EXPERIMENTAL60 day oral administration of active study drug (methylphenidate) twice per day before lunch and supper.
Interventions
Eligibility Criteria
You may qualify if:
- males and females 16 to 40 years old
- BMI in the obese category (above 29.9kg/m2)
- willing to comply with procedures, and sign informed consent forms
- able to swallow a placebo pill that will be used in the study (same size as study drug)
You may not qualify if:
- smoker (the main outcome is energy intake and smoking is known to impact appetite)
- known serious food allergies, including lactose
- history of previous MPH use or allergy to MPH
- history of ADHD or current diagnosis of an axis 1 psychiatric disorder (e.g., depression, panic disorder, schizophrenia) as measured by self-report, the Wender-Utah Rating Scale52-54 and the Beck Depression Inventory
- current use of antidepressants, thyroid medication, or any medication that could affect appetite
- high blood pressure
- pre-existing cardiovascular disorders including uncontrolled hypertension, angina pectoris, arterial occlusive disease, heart failure, cardiomypathies, myocardial infarction, and cardiac arrhythmia
- diabetes
- excessive use of alcohol or alcoholism, or current addictions to opiates, cocaine or stimulants as measured by the Drug Abuse Screening Test;
- not a restrained eater based on cut-score (11 or higher) on Three Factor Eating Questionnaire56
- glaucoma
- personal or family history of seizure disorders
- currently taking MAO inhibitors, pressor agents, coumarin, anticonvulsants, phenylbutazone, or tricyclic antidepressants
- history of thyroid disease
- personal or family history of motor tics or Tourettes's Syndrome
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital of Eastern Ontariolead
- University of Ottawacollaborator
Study Sites (2)
Children's Hospital Of Eastern Ontario Research Institute
Ottawa, Ontario, K1H8L1, Canada
University of Ottawa
Ottawa, Ontario, K1N6N5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Eric Doucet, PhD
University of Ottawa
- PRINCIPAL INVESTIGATOR
Philippe Robaey, MD, FRCPC
Childrens Hospital of Eastern Ontario-Research Inst
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Qualified Investigator, MD, PhD, FRCPC
Study Record Dates
First Submitted
April 12, 2016
First Posted
April 28, 2016
Study Start
January 1, 2017
Primary Completion
August 1, 2018
Study Completion
December 1, 2018
Last Updated
August 3, 2017
Record last verified: 2017-08