An observational study in Bi-Polar Disorder, Autism Spectrum Disorder (ASD) and Major Depression Disorders, sponsored by Qbtech AB. Suspended at 1 site in United States. Open to participants aged 6 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Qbtech AB · Observational
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.
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.
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.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's planned enrollment of 300 is above the median of 159 across 348 observational studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Qbtech AB is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Potential study participants who meet the eligibility criteria will be identified through referrals and recruitment efforts at the participating study sites.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
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.
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.
Device: 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.
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.)
Time frame: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)
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).
Time frame: 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.
Time frame: 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.
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)
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.
Time frame: 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.
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
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.
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
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).
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)
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).
Time frame: 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.
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
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.
Time frame: Visit 1 (clinic) and Visit 2 (remote, next day).
Plan to share: 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.
No publications or documents are linked to this record.
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.
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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is suspended, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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