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

Qbtech AB

Status: Invitation-only

Conditions: Attention Deficit Disorder With Hyperactivity (ADHD); Attention Deficit Disorder (ADD)

Treatments: Other: observational study

Study type: Observational

Funder types: Industry

Identifiers

NCT07217977

00082513/QB24-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 175 estimated patients

Sex: All

Ages: 6 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

175 participants in 1 patient group

ADHD

Treatment:

Other: observational study