Methylphenidate (Ritalin®) Effect During Exposure to Exercise and Heat Stress in ADD/ADHD Treated Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02704546|
Recruitment Status : Unknown
Verified March 2016 by Sheba Medical Center.
Recruitment status was: Not yet recruiting
First Posted : March 10, 2016
Last Update Posted : March 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Methylphenidate||Drug: Methylphenidate Drug: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|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 Start Date :||April 2016|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||September 2017|
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.
oral capsules (per os) each containing 10mg Methylphenidate.
Other Name: Ritalin®, MPH
Placebo Comparator: Placebo
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.
capsules identical in shape, colour and size to the Ritalin® capsules, which contain only the inactive ingredients of the same formulation.
- physiological strain (composite) [ Time Frame: 2 experimental days for each participant ]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 [ Time Frame: 2 experimental days for each participant ]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 ).
- Rectal temperature [ Time Frame: 2 experimental days for each participant ]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 [ Time Frame: 2 experimental days for each participant ]The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).
- heart rate [ Time Frame: 8 experimental days for each participant ]The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
- lactic acid [ Time Frame: 8 experimental days for each participant ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704546
|Contact: Haggai Schermann, M.D||+972828771014||Haggai.Schermann@sheba.health.gov.il|
|Sheba medical center|
|Tel-Hashomer, Ramat- Gan, Israel|
|Principal Investigator:||Haggai Schermann, M.D||Sheba Medical Center|