Recruiting

QbMobile

Sponsor:

Qbtech AB

Code:

NCT07329673

Conditions

Bi-Polar Disorder

Autism Spectrum Disorder (ASD)

Major Depression Disorders

Separation Anxiety Disorder

Social Anxiety Disorder

Eligibility Criteria

Sex: All

Age: 6 - 60

Healthy Volunteers: Not accepted

Interventions

Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)

Study Details

Brief 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.

Conditions

Bi-Polar Disorder

Autism Spectrum Disorder (ASD)

Major Depression Disorders

Separation Anxiety Disorder

Social Anxiety Disorder

Study ID

NCT07329673

Start date

Jan 1, 2026

Status verified date

May, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 60

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

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.

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.

Interventions

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.

Primary outcome measure

  • Identification of QbMobile Domain Profiles Using SD-Scores and Total Score (0-100) [ Time Frame: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2) ]

Central Contacts and Locations

Central contacts

Robert Nolen

18325370300robert.nolen@qbtech.com

Ragini Sanyal

ragini.sanyal@qbtech.com

Locations

CCM Clinical Research Group

Recruiting

Miami, Florida, United States, 33133

Contacts

CCM Clinical Research Group

305-285-0705contact@ccmclinicalresearch.com

Principal Investigator:

Francisco Ricart, MD

More Information

Sponsor

Qbtech AB

Last update posted

May 6, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Qbtech AB on 2026-05-06.