An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms
NCT ID: NCT07329673
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
300 participants
OBSERVATIONAL
2026-01-31
2026-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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ASD
Eligible participants being referred for their initial assessment or have a diagnosis of ASD but currently not receiving treatment who are attending a clinic visit at study sites will be approached by a clinic research staff about the study or contacted prior to their appointment.
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.
Bipolar disorder
Eligible participants being referred for their initial assessment or have a diagnosis of Bipolar Disorder but currently not receiving treatment who are attending a clinic visit at study sites will be approached by a clinic research staff about the study or contacted prior to their appointment.
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.
MDD
Eligible participants being referred for their initial assessment or have a diagnosis of MDD but currently not receiving treatment who are attending a clinic visit at study sites will be approached by a clinic research staff about the study or contacted prior to their appointment.
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.
Separation Anxiety Disorder
Eligible participants being referred for their initial assessment or have a diagnosis of Separation Anxiety Disorder but currently not receiving treatment who are attending a clinic visit at study sites will be approached by a clinic research staff about the study or contacted prior to their appointment.
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.
Social Anxiety Disorder
Eligible participants being referred for their initial assessment or have a diagnosis of Social Anxiety Disorder but currently not receiving treatment who are attending a clinic visit at study sites will be approached by a clinic research staff about the study or contacted prior to their appointment.
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.
Generalized Anxiety Disorder
Eligible participants being referred for their initial assessment or have a diagnosis of Generalized Anxiety Disorder but currently not receiving treatment who are attending a clinic visit at study sites will be approached by a clinic research staff about the study or contacted prior to their appointment.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
6 Years
60 Years
ALL
No
Sponsors
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Qbtech AB
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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Pro00090568 QB25-01
Identifier Type: -
Identifier Source: org_study_id
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