Using QbMobile to help tell ADHD-like symptoms apart from autism, depression, bipolar disorder, and anxiety

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

This project tests whether the QbMobile app can collect objective data to help distinguish ADHD-like symptoms from autism, depression, bipolar disorder, or anxiety in people ages 6 to 59.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 6 Years to 60 Years
• Sex: All
• Sponsor: Qbtech AB (Industry-sponsored)
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT07329673 on ClinicalTrials.gov

What this trial studies

Participants aged 6–59 who are being evaluated for or have a prior diagnosis of ASD, major depressive disorder, bipolar disorder, or an anxiety disorder and are not currently receiving treatment will complete a 10-minute QbMobile test on a compatible iPhone during a scheduled clinic visit. They will repeat the same test remotely the next day at the same time ±3 hours to assess short-term within-person variability. The study breaks protocol endpoints into individual QbMobile metrics (domain SD-scores, a 0–100 total score, classification accuracy percentages, and variability estimates) to permit clear reporting. Collected data will be used to identify symptom-domain profiles and measure how well the app classifies diagnoses that commonly overlap with ADHD symptoms.

Who should consider this trial

Good fit: Ideal candidates are people aged 6–59 who are being evaluated for or have a prior diagnosis of ASD, MDD, bipolar disorder, or an anxiety disorder, are not currently receiving treatment, have adequate sensory and physical ability, and have access to a compatible iPhone.

Not a fit: Patients with intellectual disability (IQ < 70), a current schizophrenia-spectrum diagnosis, those already receiving treatment for the target conditions, or those without a compatible iPhone are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, QbMobile could give clinicians quick, objective data to help distinguish ADHD-like symptoms from other psychiatric conditions, supporting more accurate diagnoses and targeted care.

How similar studies have performed: Objective attention and cognitive-measurement tools, including prior Qbtech products, have shown promising support in ADHD assessment, but applying a mobile app like QbMobile for differential diagnosis across ASD, mood, and anxiety disorders is relatively novel and less validated.

Eligibility criteria

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.

Where this trial is running

Miami, Florida

• CCM Clinical Research Group — Miami, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Robert Nolen

Conditions Bi-Polar Disorder; Autism Spectrum Disorder; Major Depression Disorders; Separation Anxiety Disorder; Social Anxiety Disorder; Generalized Anxiety Disorder