Bi-Polar DisorderNCT07329673

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

An observational study of Bi-Polar Disorder and Autism Spectrum Disorder (ASD), run by Qbtech AB at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 6 to 60 years
Conditions the study is for: Bi-Polar Disorder, Autism Spectrum Disorder (ASD), Major Depression Disorders
What is being tested?: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)
Type of treatment: Medical device
How many people: 300 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2026to Nov 2027
Phase: Observational
Are there results?: None posted in the registry

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: Potential study participants who meet the eligibility criteria will be identified through referrals and recruitment efforts at the participating study sites.

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 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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

CCM Clinical Research Group
Miami, Florida, 33133

Other trials in United States

About this study

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

Read the detailed description

This study aims to evaluate the performance of QbMobile in children, adolescents, and adults assessed for and diagnosed with ASD (Autism Spectrum Disorder, MDD (Major Depressive Disorder), Bipolar Disorder, or Anxiety Disorder, or has a prior diagnosis of one of the included disorders but is not currently receiving treatment. 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 at the same time as the previous test +/-3 hours. Participants will be asked to complete QbMobile prior to initiating any treatment.

Note on Outcome Measures Presentation:

The IRB-approved protocol defines endpoints broadly (e.g., identification of QbMobile domain profiles, classification accuracy, variability, and exploratory analyses). To comply with ClinicalTrials.gov requirements that each outcome measure represent a single assessment with a single unit of measure, these endpoints are operationalized into separate outcome measures corresponding to individual QbMobile metrics (domain SD-scores, Total Score [0-100], accuracy percentages, variability estimates).

This operationalization does not introduce new scientific endpoints or alter study objectives, design, or analyses. It ensures clarity and compliance for registry reporting while maintaining alignment with the approved protocol.

Conditions: Bi-Polar Disorder, Autism Spectrum Disorder (ASD), Major Depression Disorders, Separation Anxiety Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder (GAD)
Being tested: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)
Medical subject headings: Bipolar Disorder, Autism Spectrum Disorder, Anxiety, Separation, Phobia, Social, Generalized Anxiety Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07329673
Study group	Role	What they receive
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. Receives: Device: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)
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. Receives: Device: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)
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. Receives: Device: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)
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. Receives: Device: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)
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. Receives: Device: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)
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. Receives: Device: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)

What is being measured

The primary outcome is the main question the study is designed to answer.

Identification of QbMobile Domain Profiles Using SD-Scores and Total Score (0-100)
QbMobile is a software application that measures cognitive performance and activity levels, including attention, impulsivity, activity, and movement patterns. The study will identify statistically distinct QbMobile domain profiles for each diagnostic group (ASD, MDD, Bipolar Disorder, Anxiety Disorder) using domain SD-scores and the QbMobile Total Score (0-100). (Component metrics are listed as secondary outcomes to meet single-measure reporting requirements.)
Measured: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)

Secondary outcomes (10)

QbMobile Domain SD-Scores (Attention, Impulsivity, Activity, Movement) - Group Differences
QbMobile is a software application that measures cognitive performance and activity levels. Domain scores will be analyzed as SD-scores to assess differences among diagnostic groups (ASD, MDD, Bipolar Disorder, Anxiety Disorder).
Measured: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)
QbMobile Total Score (0-100) - Group Differences
QbMobile is a software application that measures cognitive performance and activity levels. The Total Score (0-100; higher values indicate greater likelihood of ADHD symptomatology) will be compared across diagnostic groups to assess differences.
Measured: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)
Classification Accuracy Using QbMobile Domain SD-Scores
QbMobile is a software application that measures cognitive performance and activity levels. Classification accuracy among diagnostic groups will be evaluated using domain SD-scores; metrics will include sensitivity, specificity, and predictive values.
Measured: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)
Classification Accuracy Using QbMobile Total Score (0-100)
QbMobile is a software application that measures cognitive performance and activity levels. Classification accuracy among diagnostic groups will be evaluated using the Total Score; metrics will include sensitivity, specificity, and predictive values based on prespecified thresholds.
Measured: QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2)
Comparison of QbMobile Domain SD-Scores with Normative Dataset
QbMobile is a software application that measures cognitive performance and activity levels. Domain SD-scores will be compared with the age- and sex-adjusted normative dataset to identify differences between diagnostic groups and normative patterns.
Measured: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2).
Comparison of QbMobile Total Score (0-100) with Normative Distribution
QbMobile is a software application that measures cognitive performance and activity levels. Total Scores will be compared with the normative distribution to identify deviations from expected values.
Measured: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2).
Variability in Differentiation Using QbMobile Domain SD-Scores
QbMobile is a software application that measures cognitive performance and activity levels. Variability in group differentiation will be assessed using domain SD-scores (e.g., confidence intervals and variance estimates across repeated measures).
Measured: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2).
Variability in Differentiation Using QbMobile Total Score (0-100)
QbMobile is a software application that measures cognitive performance and activity levels. Variability will be assessed using Total Scores (e.g., confidence intervals and variance estimates across repeated measures).
Measured: QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2).
Exploratory Analysis of Additional QbMobile Domain Parameters (SD-Based)
Consistent with the protocol statement that "all data collected from QbMobile during this study will be available to explore additional domain parameters," exploratory analyses will examine QbMobile domain data using SD-based metrics to identify additional parameters for further analysis.
Measured: QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2).
Exploratory Analysis of Additional QbMobile Parameters from Total Score and Raw Performance Data
Consistent with the protocol statement that "all data collected from QbMobile… will be available to explore additional domain parameters," exploratory analyses will use the QbMobile Total Score (0-100) and raw performance data (e.g., response time, error counts, movement traces) to identify additional parameters for further analysis.
Measured: Visit 1 (clinic) and Visit 2 (remote, next day).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 2026Nov 2027

First posted9 Jan 2026
Study start1 Jan 2026
Primary completionNov 2027 (estimated)
Study completionNov 2027 (estimated)

Why it stopped: Enrollment/study activities have been temporarily suspended while the sponsor evaluates internal study priorities and resource allocation. The suspension is not related to participant safety, protocol compliance, data quality, or regulatory concerns.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bi-Polar DisorderStudies 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: Case only
Time perspective: Prospective
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07329673
Sponsor's protocol ID: Pro00090568 QB25-01
Status last verified: Sep 2026
First submitted: 11 Dec 2025
Last updated: 25 Sep 2026
Results posted: No
Data monitoring committee: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms.
ClinicalTrials.gov ID: NCT07329673
Acronym / sponsor ID: Pro00090568 QB25-01
Conditions: Bi-Polar Disorder, Autism Spectrum Disorder (ASD), Major Depression Disorders, Separation Anxiety Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder (GAD)
Study type: Observational
Recruitment status: SuspendedReason stopped: Enrollment/study activities have been temporarily suspended while the sponsor evaluates internal study priorities and resource allocation. The suspension is not related to participant safety, protocol compliance, data quality, or regulatory concerns.
Enrolment: 300 participants (estimated)
Lead sponsor: Qbtech ABIndustry (pharma, biotech, devices)
Study start: 1 Jan 2026 (actual)
Primary completion: Nov 2027 (estimated)
Study completion: Nov 2027 (estimated)
First posted: 9 Jan 2026 (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.

Detailed description

Note on Outcome Measures Presentation:

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 6

Arm	Type	Receives
ASD	–	Device: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)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	–	Device: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)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	–	Device: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)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	–	Device: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)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	–	Device: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)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	–	Device: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)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.

Who may qualify

Ages: 6 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: Potential study participants who meet the eligibility criteria will be identified through referrals and recruitment efforts at the participating study sites.

Key inclusion criteria (6 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 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;

Key exclusion criteria (7 listed)

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);

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
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.	Device	ASD, Bipolar disorder, Generalized Anxiety Disorder, MDD, Separation Anxiety Disorder, Social Anxiety Disorder

Primary outcome

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)
QbMobile is a software application that measures cognitive performance and activity levels, including attention, impulsivity, activity, and movement patterns. The study will identify statistically distinct QbMobile domain profiles for each diagnostic group (ASD, MDD, Bipolar Disorder, Anxiety Disorder) using domain SD-scores and the QbMobile Total Score (0-100). (Component metrics are listed as secondary outcomes to meet single-measure reporting requirements.)

10 secondary outcomes

QbMobile Domain SD-Scores (Attention, Impulsivity, Activity, Movement) - Group Differences
Time frame: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)
QbMobile Total Score (0-100) - Group Differences
Time frame: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)
Classification Accuracy Using QbMobile Domain SD-Scores
Time frame: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)
Classification Accuracy Using QbMobile Total Score (0-100)
Time frame: QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2)
Comparison of QbMobile Domain SD-Scores with Normative Dataset
Time frame: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2).
Comparison of QbMobile Total Score (0-100) with Normative Distribution
Time frame: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2).
Variability in Differentiation Using QbMobile Domain SD-Scores
Time frame: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2).
Variability in Differentiation Using QbMobile Total Score (0-100)
Time frame: QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2).
Exploratory Analysis of Additional QbMobile Domain Parameters (SD-Based)
Time frame: QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2).
Exploratory Analysis of Additional QbMobile Parameters from Total Score and Raw Performance Data
Time frame: Visit 1 (clinic) and Visit 2 (remote, next day).

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Bi-Polar Disorder and Autism Spectrum Disorder (ASD), run by Qbtech AB at 1 site 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 6 inclusion and 7 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: paused, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07329673.

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 25 Sep 2026.