RecruitingNCT07329673

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.


Sponsor

Qbtech AB

Enrollment

300 participants

Start Date

Jan 1, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 60 Years

Inclusion Criteria6

  • 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 initial assessment for ASD, MDD, Bipolar Disorder or Anxiety Disorder (Separation Anxiety Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder (GAD)) or has a prior diagnosis of one of the included disorders but is not currently receiving treatment;
  • Meets DSM-5 or ICD-11 criteria for a primary diagnosis of ASD, MDD, Bipolar Disorder or Anxiety Disorder per sites standard clinical procedures;
  • Have adequate sensory and physical ability to complete QbMobile;
  • Possess or have access to an iPhone model that supports QbMobile.

Exclusion Criteria7

  • Intellectual disability designated by IQ<70;
  • Has a DSM-5 or ICD-11 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder due to another medical condition, PTSD, antisocial personality disorder, or borderline personality disorder;
  • Has a primary diagnosis of ADHD (combined, inattentive, or hyperactivity/impulsive presentation);
  • Has a concurrent medical diagnosis that could significantly affect test performance such as brain injuries, Parkinson's disease, current epilepsy or active seizures, amyotrophic lateral sclerosis (ALS), multiple sclerosis, dementias (e.g. vascular dementia, Alzheimer disease, etc);
  • Has other conditions that could affect test performance (migraine or other types of severe headache, chronic or acute pain);
  • Use of prescription medications (e.g., anxiolytics, sedative medications) taken on the day before completing QbMobile that could significantly affect performance;
  • Substance use (e.g., alcohol, drugs) that may affect performance on the day of the tests.

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Interventions

DEVICEDigital 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.


Locations(1)

CCM Clinical Research Group

Miami, Florida, United States

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NCT07329673


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