MedDataX Logo

An Investigational Study Examining the Efficacy of QbMobile in Treatment Monitoring in Individuals With ADHD

NCT ID: NCT07217977

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-15

Study Completion Date

2026-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The current study will investigate if QbMobile can be used to improve the accuracy and objective identification of reduced ADHD symptoms in tests scores once treatment has been initiated.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This 4-week study will evaluate QbMobile's performance in monitoring ADHD treatment response. 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 before beginning their ADHD medication treatment. At week 2 and week 4, participants will take QbMobile remotely at least 1 hour after taking their ADHD medication and no longer than 4 hours post dose.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention Deficit Disorder With Hyperactivity (ADHD) Attention Deficit Disorder (ADD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ADHD

observational study

Intervention Type OTHER

observational study

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

observational study

observational study

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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 ADHD assessment or has a diagnosis of ADHD but not currently receiving any type of stimulant or nonstimulant medication treatment;
* Meets DSM-5 or ICD-11 criteria for a primary diagnosis of ADHD (combined, inattentive, or hyperactivity/impulsive presentation) per sites standard clinical care evaluation;
* Qbtech Rating Scale total score of \>24 at Visit 1;
* Have adequate sensory and physical ability to complete QbMobile;
* Possess or has access to an iPhone model that supports QbMobile.

Exclusion Criteria

* Intellectual disability designated by IQ\<75);
* Has used psychostimulant medication within 7 days prior to Visit 1;
* A concurrent medical diagnosis that could significantly affect test performance (brain injuries, Parkinson's disease, current epilepsy or active seizures, amyotrophic lateral sclerosis (ALS), multiple sclerosis, dementias (e.g., vascular dementia, Alzheimer disease, etc);
* Other conditions that could affect test performance (migraine or other types of severe headache, chronic or acute pain);
* Substance use (e.g., alcohol, drugs) that may affect performance on the day of the test.
Minimum Eligible Age

6 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Qbtech AB

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Focus-MD

Mobile, Alabama, United States

Site Status

Prodigy Psychiatric Group

San Jose, California, United States

Site Status

Bokhari Medical Consortium

Largo, Florida, United States

Site Status

Nona Pediatric Center

Orlando, Florida, United States

Site Status

Godwin Psychiatry

Goldsboro, North Carolina, United States

Site Status

MindWell Urgent Care

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

00082513/QB24-02

Identifier Type: -

Identifier Source: org_study_id