Status:

ENROLLING_BY_INVITATION

An Investigational Study Examining the Efficacy of QbMobile in Treatment Monitoring in Individuals With ADHD

Lead Sponsor:

Qbtech AB

Conditions:

Attention Deficit Disorder With Hyperactivity (ADHD)

Attention Deficit Disorder (ADD)

Eligibility:

All Genders

6-60 years

Brief Summary

The current study will investigate if QbMobile can be used to improve the accuracy and objective identification of reduced ADHD symptoms in tests scores once treatment has been initiated.

Detailed Description

This 4-week study will evaluate QbMobile's performance in monitoring ADHD treatment response. Participants will complete the 10-minute QbMobile test on their personal device during a scheduled clinica...

Eligibility Criteria

Inclusion

  • Provide written informed consent (including parent/legal guardians consent when this is required for individuals under 18 years old and assent as is required based on the age of participant) for QbMobile;
  • Aged \> 6 years and \< 60 years old;
  • Referred for an ADHD assessment or has a diagnosis of ADHD but not currently receiving any type of stimulant or nonstimulant medication treatment;
  • Meets DSM-5 or ICD-11 criteria for a primary diagnosis of ADHD (combined, inattentive, or hyperactivity/impulsive presentation) per sites standard clinical care evaluation;
  • Qbtech Rating Scale total score of \>24 at Visit 1;
  • Have adequate sensory and physical ability to complete QbMobile;
  • Possess or has access to an iPhone model that supports QbMobile.

Exclusion

  • Intellectual disability designated by IQ\<75);
  • Has used psychostimulant medication within 7 days prior to Visit 1;
  • A concurrent medical diagnosis that could significantly affect test performance (brain injuries, Parkinson's disease, current epilepsy or active seizures, amyotrophic lateral sclerosis (ALS), multiple sclerosis, dementias (e.g., vascular dementia, Alzheimer disease, etc);
  • Other conditions that could affect test performance (migraine or other types of severe headache, chronic or acute pain);
  • Substance use (e.g., alcohol, drugs) that may affect performance on the day of the test.

Key Trial Info

Start Date :

January 15 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

October 1 2026

Estimated Enrollment :

175 Patients enrolled

Trial Details

Trial ID

NCT07217977

Start Date

January 15 2025

End Date

October 1 2026

Last Update

December 31 2025

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Focus-MD

Mobile, Alabama, United States, 36607

2

Prodigy Psychiatric Group

San Jose, California, United States, 95138

3

Bokhari Medical Consortium

Largo, Florida, United States, 33770

4

Nona Pediatric Center

Orlando, Florida, United States, 32829