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.

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.

Study Overview

• Status: Recruiting
• Conditions: Social Anxiety Disorder; Separation Anxiety Disorder; Autism Spectrum Disorder (ASD); Bi-Polar Disorder; Generalized Anxiety Disorder (GAD); Major Depression Disorders
• Intervention / Treatment: Device: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Robert Nolen; Phone Number: 18325370300; Email: robert.nolen@qbtech.com
• Study Contact Backup: Name: Ragini Sanyal; Email: ragini.sanyal@qbtech.com

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33133
      • Recruiting
      • CCM Clinical Research Group
      • Contact: CCM Clinical Research Group; Phone Number: 305-285-0705; Email: contact@ccmclinicalresearch.com
      • Principal Investigator: Francisco Ricart, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Potential study participants who meet the eligibility criteria will be identified through referrals and recruitment efforts at the participating study sites.

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.	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.
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.	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.
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.	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.
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of QbMobile Domain Profiles Using SD-Scores and Total Score (0-100)	QbMobile is a software application that measures cognitive performance and activity levels, including attention, impulsivity, activity, and movement patterns. The study will identify statistically distinct QbMobile domain profiles for each diagnostic group (ASD, MDD, Bipolar Disorder, Anxiety Disorder) using domain SD-scores and the QbMobile Total Score (0-100). (Component metrics are listed as secondary outcomes to meet single-measure reporting requirements.)	Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QbMobile Domain SD-Scores (Attention, Impulsivity, Activity, Movement) - Group Differences	QbMobile is a software application that measures cognitive performance and activity levels. Domain scores will be analyzed as SD-scores to assess differences among diagnostic groups (ASD, MDD, Bipolar Disorder, Anxiety Disorder).	Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)
QbMobile Total Score (0-100) - Group Differences	QbMobile is a software application that measures cognitive performance and activity levels. The Total Score (0-100; higher values indicate greater likelihood of ADHD symptomatology) will be compared across diagnostic groups to assess differences.	Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)
Classification Accuracy Using QbMobile Domain SD-Scores	QbMobile is a software application that measures cognitive performance and activity levels. Classification accuracy among diagnostic groups will be evaluated using domain SD-scores; metrics will include sensitivity, specificity, and predictive values.	Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)
Classification Accuracy Using QbMobile Total Score (0-100)	QbMobile is a software application that measures cognitive performance and activity levels. Classification accuracy among diagnostic groups will be evaluated using the Total Score; metrics will include sensitivity, specificity, and predictive values based on prespecified thresholds.	QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2)
Comparison of QbMobile Domain SD-Scores with Normative Dataset	QbMobile is a software application that measures cognitive performance and activity levels. Domain SD-scores will be compared with the age- and sex-adjusted normative dataset to identify differences between diagnostic groups and normative patterns.	Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2).
Comparison of QbMobile Total Score (0-100) with Normative Distribution	QbMobile is a software application that measures cognitive performance and activity levels. Total Scores will be compared with the normative distribution to identify deviations from expected values.	Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2).
Variability in Differentiation Using QbMobile Domain SD-Scores	QbMobile is a software application that measures cognitive performance and activity levels. Variability in group differentiation will be assessed using domain SD-scores (e.g., confidence intervals and variance estimates across repeated measures).	Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2).
Variability in Differentiation Using QbMobile Total Score (0-100)	QbMobile is a software application that measures cognitive performance and activity levels. Variability will be assessed using Total Scores (e.g., confidence intervals and variance estimates across repeated measures).	QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2).
Exploratory Analysis of Additional QbMobile Domain Parameters (SD-Based)	Consistent with the protocol statement that "all data collected from QbMobile during this study will be available to explore additional domain parameters," exploratory analyses will examine QbMobile domain data using SD-based metrics to identify additional parameters for further analysis.	QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2).
Exploratory Analysis of Additional QbMobile Parameters from Total Score and Raw Performance Data	Consistent with the protocol statement that "all data collected from QbMobile… will be available to explore additional domain parameters," exploratory analyses will use the QbMobile Total Score (0-100) and raw performance data (e.g., response time, error counts, movement traces) to identify additional parameters for further analysis.	Visit 1 (clinic) and Visit 2 (remote, next day).

Collaborators and Investigators

• Sponsor: Qbtech AB

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Mental Disorders; Mood Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Phobic Disorders; Anxiety Disorders; Autism Spectrum Disorder; Phobia, Social; Bipolar Disorder; Anxiety, Separation; Generalized Anxiety Disorder
• Other Study ID Numbers: Pro00090568 QB25-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the nature of the research, limited access to supporting data may be granted upon reasonable request under confidentiality agreements from the corresponding sponsor.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No