Status:

ENROLLING_BY_INVITATION

An Investigational Study Examining the Cross-Validation of QbMobile in ADHD and Normative Populations

Lead Sponsor:

Qbtech AB

Conditions:

No History of ADHD

Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility:

All Genders

6-60 years

Brief Summary

The purpose of this study is to investigate QbMobile ability to collect and provide accurate and objective data which can be used to facilitate assessment and treatment procedures for ADHD in a clinic...

Detailed Description

This study aims to evaluate the performance of QbMobile in children, adolescents, and adults from the normative population, those referred for an initial ADHD assessment, and individuals with an ADHD ...

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;
  • Have no documented or suspected current or lifetime diagnosis of ADHD or referred for an initial assessment for ADHD or have a diagnosis of ADHD but not currently receiving treatment;
  • Meet 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 the past 7 days prior to Visit 1;
  • A current 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 tests.

Key Trial Info

Start Date :

January 15 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

October 1 2026

Estimated Enrollment :

700 Patients enrolled

Trial Details

Trial ID

NCT07220330

Start Date

January 15 2025

End Date

October 1 2026

Last Update

December 31 2025

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Prodigy Psychiatric Group

San Jose, California, United States, 95138

2

Bokhari Medical Consortium

Largo, Florida, United States, 33770

3

Nona Pediatric Center

Orlando, Florida, United States, 32832