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

NCT02704546 | Unknown

• 1 other identifier: SHEBA-14-1245-HS-CTIL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Methylphenidate

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Rectal temperature

  2 experimental days for each participant

• skin temperature

  2 experimental days for each participant

• heart rate

  8 experimental days for each participant

• lactic acid

  8 experimental days for each participant

Study Arms (2)

Methylphenidate

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Methylphenidate DRUG

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

Also known as: Ritalin®, MPH

Methylphenidate

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• The existence or suspicion of existing cardiac or respiratory disease.
• Infectious disease 3 days prior to the experiment.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba medical center

Tel Litwinsky, Ramat- Gan, Israel

Location

MeSH Terms

Interventions

Methylphenidate; 5,10-dihydro-5-methylphenazine

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Haggai Schermann, M.D

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haggai Schermann, M.D

CONTACT

+972828771014; Haggai.Schermann@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2016
• First Posted: March 10, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 10, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)