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

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.

Study Overview

• Status: Unknown
• Conditions: Methylphenidate
• Intervention / Treatment: Drug: Methylphenidate; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat- Gan
    • Tel-Hashomer, Ramat- Gan, Israel
      • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 23 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
physiological strain (composite)	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 experimental days for each participant
aerobic capacity	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 ).	2 experimental days for each participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rectal temperature	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 experimental days for each participant
skin temperature	The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).	2 experimental days for each participant
heart rate	The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).	8 experimental days for each participant
lactic acid	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.	8 experimental days for each participant

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: March 6, 2016
• First Submitted That Met QC Criteria: March 9, 2016
• First Posted (Estimate): March 10, 2016

Study Record Updates

• Last Update Posted (Estimate): March 10, 2016
• Last Update Submitted That Met QC Criteria: March 9, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Heat Stress Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate
• Other Study ID Numbers: SHEBA-14-1245-HS-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No