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

NCT ID: NCT02704546

Last Updated: 2016-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-09-30

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Methylphenidate

Intervention Type: DRUG

oral capsules (per os) each containing 10mg Methylphenidate.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

capsules identical in shape, colour and size to the Ritalin® capsules, which contain only the inactive ingredients of the same formulation.

Interventions

Methylphenidate

oral capsules (per os) each containing 10mg Methylphenidate.

Intervention Type: DRUG

Placebo

capsules identical in shape, colour and size to the Ritalin® capsules, which contain only the inactive ingredients of the same formulation.

Intervention Type: DRUG

Other Intervention Names

Ritalin®, MPH

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haggai Schermann, M.D

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba medical center

Tel Litwinsky, Ramat- Gan, Israel

Countries

Israel

Central Contacts

Haggai Schermann, M.D

Role: CONTACT

Haggai.Schermann@sheba.health.gov.il

+972828771014

Other Identifiers

SHEBA-14-1245-HS-CTIL

Identifier Type: -

Identifier Source: org_study_id