Methylphenidate Clinical Trial
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
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.
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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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00757029 -
Pharmacogenetic Study of Methylphenidate in Attention Deficit/Hyperactivity Disorder(ADHD)
|
Phase 4 | |
| Recruiting |
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Metabolic Mechanisms of the Electrophysiological Biomarkers for Response to Methylphenidate Treatment in Children With ADHD
|