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Trial record 6 of 441 for:    Methylphenidate

Methylphenidate (Ritalin®) Effect During Exposure to Exercise and Heat Stress in ADD/ADHD Treated Patients

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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
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Methylphenidate Drug: Methylphenidate Drug: Placebo Not Applicable

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).

  1. 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.
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Methylphenidate
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.
Drug: Methylphenidate
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.
Drug: Placebo
capsules identical in shape, colour and size to the Ritalin® capsules, which contain only the inactive ingredients of the same formulation.




Primary Outcome Measures :
  1. 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.

  2. 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 ).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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.



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Haggai Schermann, M.D +972828771014 Haggai.Schermann@sheba.health.gov.il

Locations
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Israel
Sheba medical center
Tel-Hashomer, Ramat- Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Haggai Schermann, M.D Sheba Medical Center

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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02704546     History of Changes
Other Study ID Numbers: SHEBA-14-1245-HS-CTIL
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: March 10, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Methylphenidate
Heat Stress Disorders
Wounds and Injuries
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents