ADHDPhase 4NCT04283604
The Effects of a Single Dose of Methylphenidate on Motor Performance
A Phase 4 study testing MPH in people with ADHD, run by Loewenstein Hospital at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- MPH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 27 May 2021to Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- any chronic illness other than ADHD (e.g. asthma, gastrointestinal, depression, anxiety, etc.), taking chronic medications apart from stimulant therapy.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sharon Tsuk
Netanya, 42902
Sharon Tsuk, sharontsuk1@gmail.com
About this study
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.
Read more
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.
Read the detailed description
200 healthy physical education students and Mechina from the Academic College at Wingate, males and females, will be recruited to the study. 100 participants diagnosed with ADHD will serve as the treatment group and 100 non-ADHD diagnosed will serve as a control group.
Recruitment procedure will consist of emails to all students in college or by entering classes or zoom meetings. Volunteers answering the mail or providing their contact details will be regarded as giving consent to be addressed by the research assistant by a phone call. A research assistant will call volunteers and will briefly explain the study procedures and invite them to the first session in which they will sign an informed consent form approved by the institutional review board (Helsinki). Next, all participants will fill a general background questionnaire and an ADHD self-report scale questionnaire.
The second and third sessions will consist of motor tests, at least one week apart. In one of the sessions, ADHD volunteers will kindly be asked to arrive to the session before they took their stimulant medication or to come to the session after consuming their usual treatment (1 hour before the session begins). The order of sessions with or without treatment will be randomly decided. The investigators point out that the patient takes his own treatment himself when assigned to the ADHD treatment group. The non-ADHD control group (50 participants) will perform the two sessions without medications - to assess a learning effect.
The background questionnaire consists of general information relevant for the study. This includes name, gender, anthropometrical characteristics, chronic illness, regular medication consumption, etc. In addition, the participant will answer questions regarding diagnosis of ADHD, MPH consumption and physical activity participation.
The participants will fill the Adult ADHD Self Report Screen (ASRS) in Hebrew. This form was shown to be valid, reliable and had good internal consistence. This screen will be used for correlation analysis oh ADHD severity and exercise performance. The form is attached in this proposal.
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, 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. Since there may be participant who needs to take the medication every day, they will be instructed to consume their medication at the end of the session. In this case, session meeting will be performed at morning time.
Motor tests Balance test One-leg blind balance test will be performed. The maximum number of seconds a participant is able to stand without toppling or putting a foot down will be noted. Participants will stand on both legs with eyes open, facing forward, and then lift one leg with eyes closed, facing forward on a marked site. Time recording will be stopped when participants will begin to teeter; put the foot on the floor or open their eyes. Two attempts (one for each leg) will be made, and the higher value of these two attempts will be used.
Agility tests Two agility tests will be performed twice, 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 on a sports hall. These two agility tests were evaluated and validated elsewhere.
Zigzag test- Running agility test. Participant is required to run a course in the shortest possible time A zigzag course consists of a rectangle 3 X 5 meters set out at 100º angles by four cones placed on the corners, with one more cone placed in the center (Fig 1). Overall there are 6 segments numbered from 1-6 according to their order in the test. This test measures rapid acceleration, deceleration and balance control
Fig 1. Schematic representation of the Zigzag Test. Noted the start and stop points. The pathways are indicated as arrows and are numbered according to their order in the test. Triangles indicates cones.
Zigzag with a ball- The same as the former test (fig 1), but with a ball. Participants will be instructed to run as fast as possible with the ball. This test measures rapid acceleration, deceleration and balance control as well as controlling the ball.
Accuracy motor tests The stationary free throw shooting test- Each participant will perform three series of ten free-throw shots (two throws in five different positions) with a 3-minute rest period between the series. Two participants will be positioned below the hoop and they will pass the ball to the testee. After the participant completes ten shots, another participant will come to the free throw line and will perform the same task. The average scores of the all three trials will be used for analysis.
Fig 2. Schematic representation of the stationary free throw shooting test. Arrows indicate shooting positions. Order of the throwing positions are numbered.
The dynamic 60-second free throw shooting test- For easier organization of the testing a volleyball court will be used as illustrated in Figure 1. Each participant will perform five series of two free throws with sprinting between the series. Each series will be completed in 12 seconds. Each participant will start the test with an 18-meter sprint (volleyball court sideline), then will turn around a cone and run to the free throw line. After performing two free throws the participant will run to another cone where he will wait for a sound signal to start the next series. One tester will use a stopwatch to measure 12 seconds, and to give a signal to the participant. Another tester will count the number of free throws made. Two other participants will pass the balls to the testee. The participants will perform the three dynamic tests with a five-minute recovery between each. The average scores of all three trials will be used for analysis.
Fig 2. The dynamic 60-second free throw shooting test.
Measurements Blood pressure- blood pressure will be measured at the beginning of each session. Peak BP will be measured at the end of the last motor test at each session. BP will be measured by using a mercury sphygmomanometer.
Body temperature- body temperature will be measured sublingually at the beginning of each session. Peak BP will be measured at the end of the last motor test at each session. Temperature will be measured by using an electronic thermometer.
Heart rate- resting heart rates will be recorded at the beginning of each session, and at the end of the last motor test. HR will be measured by a polar watch (Polar heart rate monitor S 710).
RPE scale- To measure subjective sense of effort the Borg rate of perceived exertion (RPE) scale (ranges from 6 to 20) will be used at the end of the last motor test at each session.
- Conditions
- ADHD
- Being tested
- MPH
- Keywords
- Concerta, Physical Activity, Motor test, Exercise, Ritalin
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPHDrug
Also called Concerta, Ritalin
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.
| Study group | Role | What they receive |
|---|---|---|
| ADHD with MPH | Experimental | ADHD participants, taking MPH before the second session Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 10 min
Secondary outcomes (4)
Blood pressure (BP)
BP will be measured before and after motor test by using a mercury sphygmomanometer.
Measured: 1 min X 2 times
Body Temperature
body temperature will be measured sublingually at the beginning and at the end of each motor test using an electronic thermometer
Measured: 1 min X 2 times
Heart rate (HR)
Heart rates will be continuously recorded throughout the test (Polar heart rate monitor S 710). HR before and after the tests will be recorded
Measured: Continuously for 10 min
Rate of Perceived exertion (RPE) scale
To measure subjective sense of effort we will use the Borg rate of perceived exertion (RPE) scale (ranges from 6 to 20) at the end of each motor test.
Measured: 10 sec X 2 times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start27 May 2021
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loewenstein Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University, Wingate Institute
- Responsible party
- Principal investigator, Aviva Mimouni-Bloch, Loewenstein Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283604
- Sponsor's protocol ID
- 0007-19-LOE
- Status last verified
- Dec 2023
- First submitted
- 22 Feb 2020
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2. doi: 10.1590/s2317-17822013000200017. No abstract available.
PubMed 24413388Huss 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.
PubMed 28740389Zimmer 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.
PubMed 28450072Shorer 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.
PubMed 23580740Ben-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.
PubMed 18266665Cordeiro 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.
PubMed 29069229King 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.
PubMed 28277403Swart 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.
PubMed 19052141Roelands 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.
PubMed 18408610Marcora 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.
PubMed 26497149Stray 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.
PubMed 20298494Klass 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.
PubMed 22776872Kang 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.
PubMed 26756111Bart 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.
PubMed 23584172Meckel 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Single Dose of Methylphenidate on Motor Performance
- ClinicalTrials.gov ID
- NCT04283604
- Acronym / sponsor ID
- 0007-19-LOE
- Conditions
- ADHD
- Keywords
- Concerta, Physical Activity, Motor test, Exercise, Ritalin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Loewenstein HospitalUniversity, hospital or other
- Collaborators
- Tel Aviv University, Wingate Institute
- Study start
- 27 May 2021 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
200 healthy physical education students and Mechina from the Academic College at Wingate, males and females, will be recruited to the study. 100 participants diagnosed with ADHD will serve as the treatment group and 100 non-ADHD diagnosed will serve as a control group.
Recruitment procedure will consist of emails to all students in college or by entering classes or zoom meetings. Volunteers answering the mail or providing their contact details will be regarded as giving consent to be addressed by the research assistant by a phone call. A research assistant will call volunteers and will briefly explain the study procedures and invite them to the first session in which they will sign an informed consent form approved by the institutional review board (Helsinki). Next, all participants will fill a general background questionnaire and an ADHD self-report scale questionnaire.
The second and third sessions will consist of motor tests, at least one week apart. In one of the sessions, ADHD volunteers will kindly be asked to arrive to the session before they took their stimulant medication or to come to the session after consuming their usual treatment (1 hour before the session begins). The order of sessions with or without treatment will be randomly decided. The investigators point out that the patient takes his own treatment himself when assigned to the ADHD treatment group. The non-ADHD control group (50 participants) will perform the two sessions without medications - to assess a learning effect.
The background questionnaire consists of general information relevant for the study. This includes name, gender, anthropometrical characteristics, chronic illness, regular medication consumption, etc. In addition, the participant will answer questions regarding diagnosis of ADHD, MPH consumption and physical activity participation.
The participants will fill the Adult ADHD Self Report Screen (ASRS) in Hebrew. This form was shown to be valid, reliable and had good internal consistence. This screen will be used for correlation analysis oh ADHD severity and exercise performance. The form is attached in this proposal.
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, 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. Since there may be participant who needs to take the medication every day, they will be instructed to consume their medication at the end of the session. In this case, session meeting will be performed at morning time.
Motor tests Balance test One-leg blind balance test will be performed. The maximum number of seconds a participant is able to stand without toppling or putting a foot down will be noted. Participants will stand on both legs with eyes open, facing forward, and then lift one leg with eyes closed, facing forward on a marked site. Time recording will be stopped when participants will begin to teeter; put the foot on the floor or open their eyes. Two attempts (one for each leg) will be made, and the higher value of these two attempts will be used.
Agility tests Two agility tests will be performed twice, 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 on a sports hall. These two agility tests were evaluated and validated elsewhere.
Zigzag test- Running agility test. Participant is required to run a course in the shortest possible time A zigzag course consists of a rectangle 3 X 5 meters set out at 100º angles by four cones placed on the corners, with one more cone placed in the center (Fig 1). Overall there are 6 segments numbered from 1-6 according to their order in the test. This test measures rapid acceleration, deceleration and balance control
Fig 1. Schematic representation of the Zigzag Test. Noted the start and stop points. The pathways are indicated as arrows and are numbered according to their order in the test. Triangles indicates cones.
Zigzag with a ball- The same as the former test (fig 1), but with a ball. Participants will be instructed to run as fast as possible with the ball. This test measures rapid acceleration, deceleration and balance control as well as controlling the ball.
Accuracy motor tests The stationary free throw shooting test- Each participant will perform three series of ten free-throw shots (two throws in five different positions) with a 3-minute rest period between the series. Two participants will be positioned below the hoop and they will pass the ball to the testee. After the participant completes ten shots, another participant will come to the free throw line and will perform the same task. The average scores of the all three trials will be used for analysis.
Fig 2. Schematic representation of the stationary free throw shooting test. Arrows indicate shooting positions. Order of the throwing positions are numbered.
The dynamic 60-second free throw shooting test- For easier organization of the testing a volleyball court will be used as illustrated in Figure 1. Each participant will perform five series of two free throws with sprinting between the series. Each series will be completed in 12 seconds. Each participant will start the test with an 18-meter sprint (volleyball court sideline), then will turn around a cone and run to the free throw line. After performing two free throws the participant will run to another cone where he will wait for a sound signal to start the next series. One tester will use a stopwatch to measure 12 seconds, and to give a signal to the participant. Another tester will count the number of free throws made. Two other participants will pass the balls to the testee. The participants will perform the three dynamic tests with a five-minute recovery between each. The average scores of all three trials will be used for analysis.
Fig 2. The dynamic 60-second free throw shooting test.
Measurements Blood pressure- blood pressure will be measured at the beginning of each session. Peak BP will be measured at the end of the last motor test at each session. BP will be measured by using a mercury sphygmomanometer.
Body temperature- body temperature will be measured sublingually at the beginning of each session. Peak BP will be measured at the end of the last motor test at each session. Temperature will be measured by using an electronic thermometer.
Heart rate- resting heart rates will be recorded at the beginning of each session, and at the end of the last motor test. HR will be measured by a polar watch (Polar heart rate monitor S 710).
RPE scale- To measure subjective sense of effort the Borg rate of perceived exertion (RPE) scale (ranges from 6 to 20) will be used at the end of the last motor test at each session.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ADHD with MPH | Experimental | Drug: MPHADHD participants, taking MPH before the second session |
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- any chronic illness other than ADHD (e.g. asthma, gastrointestinal, depression, anxiety, etc.), taking chronic medications apart from stimulant therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPHAlso: Concerta, RitalinThe 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. | Drug | ADHD with MPH |
Primary outcome
Agility tests
Time frame: 2 min
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
Accuracy motor tests
Time frame: 10 min
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.
4 secondary outcomes
Blood pressure (BP)
Time frame: 1 min X 2 times
Body Temperature
Time frame: 1 min X 2 times
Heart rate (HR)
Time frame: Continuously for 10 min
Rate of Perceived exertion (RPE) scale
Time frame: 10 sec X 2 times
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Background: PubMed 24413388Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2. doi: 10.1590/s2317-17822013000200017. No abstract available.
- Background: PubMed 28740389Huss 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.
- Background: PubMed 28450072Zimmer 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.
- Background: PubMed 23580740Shorer 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.
- Background: PubMed 18266665Ben-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.
- Background: PubMed 29069229Cordeiro 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.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MPH in people with ADHD, run by Loewenstein Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aviva Mimouni-Bloch, MD (7709085 ext. 972 9, abloch@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agility tests (time frame: 2 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04283604, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.