NCT05517785

Brief Summary

The aim of this study is to evaluate the effects of stimulant ADHD pharmacotherapy on motor performance in male adolescents.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 26, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

1.3 years

First QC Date

August 16, 2022

Last Update Submit

December 13, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • Motor tests

    Plank

    5 minutes

  • Motor tests

    Single leg stance test

    5 minutes

  • Motor tests

    Standing long jump test (broad jump)

    5 minutes

  • Motor tests

    4 x 10 agility tests

    5 minutes

  • Motor tests

    20 m shuttle run tests (beeps)

    5 minutes

  • AAC-Q questionnaire

    Adolescents and Adults Coordination Questionnaire

    10 minutes

Secondary Outcomes (2)

  • Heart rate at rest

    5 minutes

  • Blood pressure at rest

    5 minutes

Study Arms (2)

Medicated

Assessment of motor function will be performed 1 hour after taking the usual stimulant ADHD medication.

Other: Motor performance tests

Unmedicated

Participants will remain unmedicated for the duration of the assessment, and will delay taking their usual stimulant ADHD medication until all the motor function assessments are completed.

Other: Motor performance tests

Interventions

Performance of 5 motor tests: plank, single leg stance test, standing long jump test (broad jump), 4 x 10 agility test and 20 m shuttle run tests (beeps), after taking ADHD drug or not taking the drug before motor tests performance

MedicatedUnmedicated

Eligibility Criteria

Age15 Years - 18 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThis research will analyze physiological data that is sex dependent
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

70 high school boys ages 15-18 years, diagnosed with ADHD and treated with stimulant medications

You may qualify if:

  • High school male students
  • Diagnosis of ADHD
  • Treatment with prescribed stimulants for ADHD (e.g. Concerta, Ritalin, Phenidin, Focalin etc.).

You may not qualify if:

  • Students with concomitant chronic disease (including asthma, cardiac, motor, neurological and gastrointestinal disturbances)
  • History of acute illness in the previous two weeks
  • Any injuries that would inhibit the ability to exercise or play sport
  • Students unable to obtain parental/guardian consent
  • Students unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sharon Tsuk

Netanya, 42902, Israel

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Aviva Mimouni-Bloch, Prof

CONTACT

Sharon Tsuk, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Child Developmental Center

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 26, 2022

Study Start

February 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

December 20, 2023

Record last verified: 2023-12

Locations