The Effects of a Single Dose of Methylphenidate on Motor Performance

NCT04283604 | Unknown Phase 4 FDA Drug

• 1 other identifier: 0007-19-LOE
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Concerta; Physical Activity; Motor test; Exercise; Ritalin

Outcome Measures

Primary Outcomes (2)

• Agility tests

  Two agility tests (Zigzag with and without a ball) will be performed. The best time of each test will be recorded. Calculation of the ratio of zigzag test without the ball and with the ball will be conducted

  2 min

• Accuracy motor tests

  Two accuracy motor tests (the stationary free throw shooting test and the dynamic 60-second free throw shooting test) will be performed three times. The average scores of the all three trials will be used for analysis.

  10 min

Secondary Outcomes (4)

• Blood pressure (BP)

  1 min X 2 times

• Body Temperature

  1 min X 2 times

• Heart rate (HR)

  Continuously for 10 min

• Rate of Perceived exertion (RPE) scale

  10 sec X 2 times

Study Arms (3)

ADHD with MPH

EXPERIMENTAL

ADHD participants, taking MPH before the second session

Drug: MPH

ADHD no MPH

NO INTERVENTION

ADHD participants will perform motor tests in both session, without any intervention, for evaluation of learning effect among ADHD participants.

Healthy participants

NO INTERVENTION

Non-ADHD participants will serve as a control group for learning effect on motor tests

Interventions

MPH DRUG

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.

Also known as: Concerta, Ritalin

ADHD with MPH

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Students age 18-45 years old studying at the academic college at Wingate. For the treatment group we will recruit students who were previously diagnosed by a neurologist or psychiatrist or other ADHD physician specialist as having ADHD, and are treated with a methylphenidate (Ritalin; Ritalin SR; Ritalin LA; Concerta) at least 3 months before the first session. Control group will consist of students without ADHD.

You may not qualify if:

• any chronic illness other than ADHD (e.g. asthma, gastrointestinal, depression, anxiety, etc.), taking chronic medications apart from stimulant therapy.

Sponsors & Collaborators

• Loewenstein Hospital: lead
• Tel Aviv University: collaborator
• Wingate Institute: collaborator

Study Sites (1)

Sharon Tsuk

Netanya, 42902, Israel

RECRUITING

Related Publications (24)

• Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2. doi: 10.1590/s2317-17822013000200017. No abstract available.

  PMID: 24413388 BACKGROUND

• Huss M, Duhan P, Gandhi P, Chen CW, Spannhuth C, Kumar V. Methylphenidate dose optimization for ADHD treatment: review of safety, efficacy, and clinical necessity. Neuropsychiatr Dis Treat. 2017 Jul 4;13:1741-1751. doi: 10.2147/NDT.S130444. eCollection 2017.

  PMID: 28740389 BACKGROUND

• Zimmer L. Contribution of Clinical Neuroimaging to the Understanding of the Pharmacology of Methylphenidate. Trends Pharmacol Sci. 2017 Jul;38(7):608-620. doi: 10.1016/j.tips.2017.04.001. Epub 2017 Apr 24.

  PMID: 28450072 BACKGROUND

• Shorer Z, Bachner Y, Guy T, Melzer I. Effect of single dose methylphenidate on walking and postural stability under single- and dual-task conditions in older adults--a double-blind randomized control trial. J Gerontol A Biol Sci Med Sci. 2013 Oct;68(10):1271-80. doi: 10.1093/gerona/glt035. Epub 2013 Apr 11.

  PMID: 23580740 BACKGROUND

• Ben-Itzhak R, Giladi N, Gruendlinger L, Hausdorff JM. Can methylphenidate reduce fall risk in community-living older adults? A double-blind, single-dose cross-over study. J Am Geriatr Soc. 2008 Apr;56(4):695-700. doi: 10.1111/j.1532-5415.2007.01623.x. Epub 2008 Feb 7.

  PMID: 18266665 BACKGROUND

• Cordeiro LMS, Rabelo PCR, Moraes MM, Teixeira-Coelho F, Coimbra CC, Wanner SP, Soares DD. Physical exercise-induced fatigue: the role of serotonergic and dopaminergic systems. Braz J Med Biol Res. 2017 Oct 19;50(12):e6432. doi: 10.1590/1414-431X20176432.

  PMID: 29069229 BACKGROUND

• King M, Rauch LHG, Brooks SJ, Stein DJ, Lutz K. Methylphenidate Enhances Grip Force and Alters Brain Connectivity. Med Sci Sports Exerc. 2017 Jul;49(7):1443-1451. doi: 10.1249/MSS.0000000000001252.

  PMID: 28277403 BACKGROUND

• Swart J, Lamberts RP, Lambert MI, St Clair Gibson A, Lambert EV, Skowno J, Noakes TD. Exercising with reserve: evidence that the central nervous system regulates prolonged exercise performance. Br J Sports Med. 2009 Oct;43(10):782-8. doi: 10.1136/bjsm.2008.055889. Epub 2008 Dec 3.

  PMID: 19052141 BACKGROUND

• Roelands B, Hasegawa H, Watson P, Piacentini MF, Buyse L, De Schutter G, Meeusen RR. The effects of acute dopamine reuptake inhibition on performance. Med Sci Sports Exerc. 2008 May;40(5):879-85. doi: 10.1249/MSS.0b013e3181659c4d.

  PMID: 18408610 BACKGROUND

• Marcora S. Can Doping be a Good Thing? Using Psychoactive Drugs to Facilitate Physical Activity Behaviour. Sports Med. 2016 Jan;46(1):1-5. doi: 10.1007/s40279-015-0412-x. No abstract available.

  PMID: 26497149 BACKGROUND

• Stray LL, Ellertsen B, Stray T. Motor function and methylphenidate effect in children with attention deficit hyperactivity disorder. Acta Paediatr. 2010 Aug;99(8):1199-204. doi: 10.1111/j.1651-2227.2010.01760.x. Epub 2010 Mar 12.

  PMID: 20298494 BACKGROUND

• Klass M, Roelands B, Levenez M, Fontenelle V, Pattyn N, Meeusen R, Duchateau J. Effects of noradrenaline and dopamine on supraspinal fatigue in well-trained men. Med Sci Sports Exerc. 2012 Dec;44(12):2299-308. doi: 10.1249/MSS.0b013e318265f356.

  PMID: 22776872 BACKGROUND

• Kang KD, Yun SW, Chung U, Kim TH, Park JH, Park IH, Han DH. Effects of methylphenidate on body index and physical fitness in Korean children with attention deficit hyperactivity disorder. Hum Psychopharmacol. 2016 Mar;31(2):76-82. doi: 10.1002/hup.2514. Epub 2016 Jan 12.

  PMID: 26756111 BACKGROUND

• Bart O, Daniel L, Dan O, Bar-Haim Y. Influence of methylphenidate on motor performance and attention in children with developmental coordination disorder and attention deficit hyperactive disorder. Res Dev Disabil. 2013 Jun;34(6):1922-7. doi: 10.1016/j.ridd.2013.03.015. Epub 2013 Apr 10.

  PMID: 23584172 BACKGROUND

• Meckel Y, Nemet D, Eliakim A. the Effect of Methylphenidate Treatment on Exercise Performance in Children With Attention-Deficit Hyperactivity Disorder. Acta Kinesiol. Univ. Tartu 7:109-16, 2011

  BACKGROUND

• De Crescenzo F, Armando M, Mazzone L, Ciliberto M, Sciannamea M, Figueroa C, Janiri L, Quested D, Vicari S. The use of actigraphy in the monitoring of methylphenidate versus placebo in ADHD: a meta-analysis. Atten Defic Hyperact Disord. 2014 Mar;6(1):49-58. doi: 10.1007/s12402-013-0122-x. Epub 2013 Nov 28.

  PMID: 24287735 BACKGROUND

• Edvinsson D, Ekselius L. Long-Term Tolerability and Safety of Pharmacological Treatment of Adult Attention-Deficit/Hyperactivity Disorder: A 6-Year Prospective Naturalistic Study. J Clin Psychopharmacol. 2018 Aug;38(4):370-375. doi: 10.1097/JCP.0000000000000917.

  PMID: 29927781 BACKGROUND

• Zohar AH, Konfortes H. Diagnosing ADHD in Israeli adults: the psychometric properties of the adult ADHD Self Report Scale (ASRS) in Hebrew. Isr J Psychiatry Relat Sci. 2010;47(4):308-15.

  PMID: 21270505 BACKGROUND

• Mirkov D, Nedeljkovic A, Kukolj M, Ugarkovic D, Jaric S. Evaluation of the reliability of soccer-specific field tests. J Strength Cond Res. 2008 Jul;22(4):1046-50. doi: 10.1519/JSC.0b013e31816eb4af.

  PMID: 18545209 BACKGROUND

• Masuda S, Suganuma K, Kaneko C, Hoshina K, Suzuki T, Serita T, Sakakibara R. Prediction of Falls Using a 3-m Zigzag Walk Test. J Phys Ther Sci. 2013 Sep;25(9):1051-4. doi: 10.1589/jpts.25.1051. Epub 2013 Oct 20.

  PMID: 24259913 BACKGROUND

• Aquino R, Palucci Vieira LH, de Paula Oliveira L, Cruz Goncalves LG, Pereira Santiago PR. Relationship between field tests and match running performance in high-level young Brazilian soccer players. J Sports Med Phys Fitness. 2018 Mar;58(3):256-262. doi: 10.23736/S0022-4707.17.06651-8. Epub 2017 Feb 14.

  PMID: 28198600 BACKGROUND

• Archer DT, Drysdale K, Bradley EJ. Differentiating technical skill and motor abilities in selected and non-selected 3-5 year old team-sports players. Hum Mov Sci. 2016 Jun;47:81-87. doi: 10.1016/j.humov.2016.02.001. Epub 2016 Feb 22.

  PMID: 26904973 BACKGROUND

• Pojskic H, Muratovic M. The relationship between physical fitness and shooting accuracy of professional basketball players 20:1-13, 2014

  BACKGROUND

• Borg GA. Perceived exertion. Exerc Sport Sci Rev. 1974;2:131-53. No abstract available.

  PMID: 4466663 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Motor Activity

Interventions

5,10-dihydro-5-methylphenazine; Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Aviva Mimouni-Bloch, MD

CONTACT

7709085; abloch@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of child developmental center

Model Details: The study will be divided into two sub studies (100 participants each), in which 50 ADHD and 50 non-ADHD participants will be included. In the first session, all participants will undergo motor tests, in the same conditions. In the second session, half of ADHD participants (25) will be asked to take their regular MPH treatment, before the session. All other participants (25 ADHD and 50 non-ADHD) will perform the motor tests without treatment, and serve as control groups.

Study Record Dates

• First Submitted: February 22, 2020
• First Posted: February 25, 2020
• Study Start: May 27, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)