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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02704546
• Other study ID #: SHEBA-14-1245-HS-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: March 6, 2016
• Last updated: March 9, 2016
• Start date: April 2016
• Est. completion date: September 2017

Study information

• Verified date: March 2016
• Source: Sheba Medical Center
• Contact: Haggai Schermann, M.D
• Phone: +972828771014
• Email: Haggai.Schermann[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Methylphenidate

Intervention

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

Locations

Country	Name	City	State
Israel	Sheba medical center	Tel-Hashomer	Ramat- Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	Yes
Secondary	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	No