NCT02704546

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

The Effect of the Drug Methylphenidate on Physiological Stress and Function During Exposure to Exercise and Heat Stress in ADD/ADHD Treated Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: Male
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

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). 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.

Conditions

• Methylphenidate

Interventions

Type	Name	Description
DRUG	Methylphenidate	oral capsules (per os) each containing 10mg Methylphenidate.
DRUG	Placebo	capsules identical in shape, colour and size to the Ritalin® capsules, which contain only the inactive ingredients of the same formulation.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-04-01
• Completion: 2017-09-01
• First posted: 2016-03-10
• Last updated: 2016-03-10

Locations

1 site across 1 country: Israel