Methylphenidate (Ritalin®) Effect During Exposure to Exercise and Heat Stress in ADD/ADHD Treated Patients
Primary Purpose
Methylphenidate
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Methylphenidate
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Methylphenidate
Eligibility Criteria
Inclusion Criteria:
- Civilian volunteers aged 18-25 years.
- BMI range of 17-25.
- Diagnosed with attention deficit disorder (ADD or ADHD) since childhood.
- Routine use of Methylphenidate (at least 5 days a week).
- Without known medical illness or medication use.
- Report of performing physical exercise (twice or more a week).
- Without history of heat injury.
Exclusion Criteria:
- The existence or suspicion of existing cardiac or respiratory disease.
- Infectious disease 3 days prior to the experiment.
Sites / Locations
- Sheba medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Methylphenidate
Placebo
Arm Description
In experimental days taking MPH, subjects will take 20mg Ritalin® (Novartis AG) in two tablets of 10mg, by swallow 1 hour prior to performing the physical test.
In experimental days with placebo subjects will be asked to ingest 2 capsules identical to Ritalin® capsules, by swallow 1 hour prior to performing the physical test.
Outcomes
Primary Outcome Measures
physiological strain (composite)
the physiological strain will be determined by monitoring body core temperature and heart rate of the subjects during a Heat Tolerant Test (HTT). the test is performed in a climatic chamber. during the test the subjects walks on a treadmill (5 km/h and 2% incline) for 2h.
aerobic capacity
the aerobic capacity of the subjects will be determined by performing a maximal oxygen consumption test (VO2max). VO2 will be monitored continuously with a metabolic system (ERGOTEST 680, ZAN, GERMANY ).
Secondary Outcome Measures
Rectal temperature
rectal temperature will be recorded at a depth of 10 mm past the anal sphincter using YSI-401 thermal thermistor during each heat tolerance test (HTT).
skin temperature
The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).
heart rate
The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
lactic acid
lactic acid level is assessed from blood drop (finger sting), will be taken before and after every test. lactic acid is a marker for anaerobic effort evaluating.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02704546
Brief Title
Methylphenidate (Ritalin®) Effect During Exposure to Exercise and Heat Stress in ADD/ADHD Treated Patients
Official Title
The Effect of the Drug Methylphenidate on Physiological Stress and Function During Exposure to Exercise and Heat Stress in ADD/ADHD Treated Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to explore the possible effects of MPH use on physiological functions among ADHD\ADD patients, by performing a set of physical trials to assess aerobic and anaerobic capacity, to characterize the tendency for muscle break down while performing monitored moderate physical effort and to assess the physiological strain while performing moderate exercise in heat load conditions by using the heat tolerance test.
Detailed Description
20 male, non-combat soldiers with a pre-existing childhood diagnosis of ADHD\ADD, who are chronically treated with MPH will participate in the study. If necessary, civilian volunteers with a childhood diagnosis of ADHD\ADD may also be recruited to complete the study population (up to 50%, i.e. 10 participants).
st encounter: the subjects will receive an explanation of the study and sign an informed consent form, complete a medical questionnaire and undergo physical examination by a physician, including ECG.
nd-9th encounter: the subjects will be requested to undergo 10 tests on 8 examination days, which will include the: maximal oxygen consumption test, wingate test, heat tolerance test and step test. Each subject will perform each test twice: once while taking MPH and once with placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methylphenidate
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Methylphenidate
Arm Type
Experimental
Arm Description
In experimental days taking MPH, subjects will take 20mg Ritalin® (Novartis AG) in two tablets of 10mg, by swallow 1 hour prior to performing the physical test.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
In experimental days with placebo subjects will be asked to ingest 2 capsules identical to Ritalin® capsules, by swallow 1 hour prior to performing the physical test.
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Other Intervention Name(s)
Ritalin®, MPH
Intervention Description
oral capsules (per os) each containing 10mg Methylphenidate.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
capsules identical in shape, colour and size to the Ritalin® capsules, which contain only the inactive ingredients of the same formulation.
Primary Outcome Measure Information:
Title
physiological strain (composite)
Description
the physiological strain will be determined by monitoring body core temperature and heart rate of the subjects during a Heat Tolerant Test (HTT). the test is performed in a climatic chamber. during the test the subjects walks on a treadmill (5 km/h and 2% incline) for 2h.
Time Frame
2 experimental days for each participant
Title
aerobic capacity
Description
the aerobic capacity of the subjects will be determined by performing a maximal oxygen consumption test (VO2max). VO2 will be monitored continuously with a metabolic system (ERGOTEST 680, ZAN, GERMANY ).
Time Frame
2 experimental days for each participant
Secondary Outcome Measure Information:
Title
Rectal temperature
Description
rectal temperature will be recorded at a depth of 10 mm past the anal sphincter using YSI-401 thermal thermistor during each heat tolerance test (HTT).
Time Frame
2 experimental days for each participant
Title
skin temperature
Description
The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).
Time Frame
2 experimental days for each participant
Title
heart rate
Description
The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
Time Frame
8 experimental days for each participant
Title
lactic acid
Description
lactic acid level is assessed from blood drop (finger sting), will be taken before and after every test. lactic acid is a marker for anaerobic effort evaluating.
Time Frame
8 experimental days for each participant
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Civilian volunteers aged 18-25 years.
BMI range of 17-25.
Diagnosed with attention deficit disorder (ADD or ADHD) since childhood.
Routine use of Methylphenidate (at least 5 days a week).
Without known medical illness or medication use.
Report of performing physical exercise (twice or more a week).
Without history of heat injury.
Exclusion Criteria:
The existence or suspicion of existing cardiac or respiratory disease.
Infectious disease 3 days prior to the experiment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haggai Schermann, M.D
Phone
+972828771014
Email
Haggai.Schermann@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haggai Schermann, M.D
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba medical center
City
Tel-Hashomer
State/Province
Ramat- Gan
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
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Methylphenidate (Ritalin®) Effect During Exposure to Exercise and Heat Stress in ADD/ADHD Treated Patients
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