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The Effects of a Single Dose of Methylphenidate on Motor Performance

NCT04283604 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-12-20

No results posted yet for this study

Summary

Aim: To evaluate the effects of MPH on young adults diagnosed with ADHD on different exercise performance tests.

Hypothesis: MPH will have positive effects on motor tests requiring concentration.

Methods: 200 healthy physical education students, 100 participants diagnosed with ADHD will serve as the treatment group and 100 non-ADHD diagnosed will serve as a control group. The study will be divided into two sub studies (100 participants each), in which, two motor tests will be evaluated (two agility tests, two motor accuracy tests and balance).

All participants will arrive for two sessions, and will perform two motor tests in each session. In the second session, half of the participants with ADHD (25 participants) will undergo another session of the same motor tests with their usual treatment (treatment group) and another half (25 participants) without their treatment (ADHD control group). The non-ADHD control group (50 participants) will perform the second session without medications - to assess a learning effect.

Note, the investigators are not planning on giving the medication to the participant, rather he/she will consume their own prescribed MPH by them self. Control treatment for ADHD participants will consist of not taking their medication before the motor test.

For evaluation of physiological responses and perception of effort, heart rate, temperature, blood pressure and RPE before and after motor tests, will be measured.

Conditions

  • ADHD

Interventions

DRUG

MPH

The treatment will include taking the patient's own medication by the patient himself in the treatment session 60-180 minutes before the beginning of the tests, according to their prescription given by their own physician. Participants must have consumed this medication at least 3 months before the first session as their regular treatment for ADHD. Note, we are not planning on giving the medication to the participant, rather he/she will consume their own prescribed MPH by them self.

Sponsors & Collaborators

  • Tel Aviv University

    collaborator OTHER

  • Wingate Institute

    collaborator OTHER

  • Loewenstein Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-27
Primary Completion
2024-03-31
Completion
2024-03-31
FDA Drug
Yes

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04283604 on ClinicalTrials.gov