NCT07329673

An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms

An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Qbtech AB · Industry
• Sex: All
• Age: 6 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate QbMobile's ability to collect objective data to identify specific symptom profiles in differential diagnoses (ASD, MDD, Bipolar Disorder and Anxiety Disorder) that are common with ADHD.

Detailed description

This study aims to evaluate the performance of QbMobile in children, adolescents, and adults assessed for and diagnosed with ASD (Autism Spectrum Disorder, MDD (Major Depressive Disorder), Bipolar Disorder, or Anxiety Disorder, or has a prior diagnosis of one of the included disorders but is not currently receiving treatment. Participants will complete the 10-minute QbMobile test on their personal device during a scheduled clinical visit. They will then repeat the test remotely the following day at the same time as the previous test +/-3 hours. Participants will be asked to complete QbMobile prior to initiating any treatment. Note on Outcome Measures Presentation: The IRB-approved protocol defines endpoints broadly (e.g., identification of QbMobile domain profiles, classification accuracy, variability, and exploratory analyses). To comply with ClinicalTrials.gov requirements that each outcome measure represent a single assessment with a single unit of measure, these endpoints are operationalized into separate outcome measures corresponding to individual QbMobile metrics (domain SD-scores, Total Score \[0-100\], accuracy percentages, variability estimates). This operationalization does not introduce new scientific endpoints or alter study objectives, design, or analyses. It ensures clarity and compliance for registry reporting while maintaining alignment with the approved protocol.

Conditions

• Bi-Polar Disorder
• Autism Spectrum Disorder (ASD)
• Major Depression Disorders
• Separation Anxiety Disorder
• Social Anxiety Disorder
• Generalized Anxiety Disorder (GAD)

Interventions

Type	Name	Description
DEVICE	Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)	Participants will complete two non-invasive, 10-minute digital tests using the QbMobile Investigational Device-one at the clinic and one at home the following day. The tests objectively measure cognitive performance and activity levels and will not influence clinical diagnosis or treatment in this study.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2026-01-09
• Last updated: 2026-01-09