Attention Deficit Disorder With Hyperactivity (ADHD)NCT07217977
An Investigational Study Examining the Efficacy of QbMobile in Treatment Monitoring in Individuals With ADHD
An observational study of Attention Deficit Disorder With Hyperactivity (ADHD) and Attention Deficit Disorder (ADD), run by Qbtech AB at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity (ADHD), Attention Deficit Disorder (ADD)
- What is being tested?
- observational study
- How many people
- 175 participants
- Where
- 7 sitesUnited States
- Study dates
- 15 Jan 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants will be selected from referrals or participating site's ADHD data base.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
MindWell Urgent Care
Dallas, Texas, 75247
Godwin Psychiatry
Goldsboro, North Carolina, 27534
Bokhari Medical Consortium
Largo, Florida, 33770
CCM Clinical Research Group
Miami, Florida, 33133
Focus-MD
Mobile, Alabama, 36607
Nona Pediatric Center
Orlando, Florida, 32829
Prodigy Psychiatric Group
San Jose, California, 95138
About this study
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.
Read the detailed 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.
- Being tested
- observational study
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
observational study
| Study group | Role | What they receive |
|---|---|---|
| ADHD | Not described Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in QbMobile Total Score from Baseline at Visit 3 and Visit 4
Change in the QbMobile Total Score from baseline (Visit 2) will be assessed at Visit 3 and Visit 4 to evaluate treatment related responses over time. The QbMobile produces a Total Score number ranging from 0 to 100, where 0 indicates a low likelihood of exhibiting ADHD symptoms and 100 indicates a high likelihood of exhibiting ADHD symptoms. This score is automatically generated in a standard report immediately upon completion of QbMobile.
Measured: Baseline, Visit 3 (Week 2), and Visit 4 (Week 4)
Secondary outcomes (1)
Change in QbMobile SD-scores from Baseline at Visit 3 and Visit 4
Change in the QbMobile SD-scores (Standard Deviation scores) from baseline (Visit 2) will be assessed at Visit 3 and Visit 4 to evaluate treatment-related effects over time. QbMobile SD-scores are standardized metrics derived from the main parameters (attention, impulsivity, activity and movement). These scores are calculated using and age and sex at birth adjusted normative dataset. The SD-scores are produced in the QbMobile report generated after completion of QbMobile.
Measured: Baseline, Visit 3 (Week 2), and Visit 4 (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start15 Jan 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With Hyperactivity (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qbtech AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217977
- Sponsor's protocol ID
- 00082513/QB24-02
- Status last verified
- May 2026
- First submitted
- 15 Oct 2025
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigational Study Examining the Efficacy of QbMobile in Treatment Monitoring in Individuals With ADHD
- ClinicalTrials.gov ID
- NCT07217977
- Acronym / sponsor ID
- 00082513/QB24-02
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Qbtech ABIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADHD | – | Other: observational study |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants will be selected from referrals or participating site's ADHD data base.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyobservational study | Other | ADHD |
Primary outcome
Change in QbMobile Total Score from Baseline at Visit 3 and Visit 4
Time frame: Baseline, Visit 3 (Week 2), and Visit 4 (Week 4)
Change in the QbMobile Total Score from baseline (Visit 2) will be assessed at Visit 3 and Visit 4 to evaluate treatment related responses over time. The QbMobile produces a Total Score number ranging from 0 to 100, where 0 indicates a low likelihood of exhibiting ADHD symptoms and 100 indicates a high likelihood of exhibiting ADHD symptoms. This score is automatically generated in a standard report immediately upon completion of QbMobile.
1 secondary outcome
Change in QbMobile SD-scores from Baseline at Visit 3 and Visit 4
Time frame: Baseline, Visit 3 (Week 2), and Visit 4 (Week 4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Disorder With Hyperactivity (ADHD) and Attention Deficit Disorder (ADD), run by Qbtech AB at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in QbMobile Total Score from Baseline at Visit 3 and Visit 4 (time frame: Baseline, Visit 3 (Week 2), and Visit 4 (Week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.