An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms
Recruiting · NCT07329673 · Observational (researchers observe without assigning treatment) · Lead sponsor: Qbtech AB
View the official record on ClinicalTrials.gov →Interventions studied
Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)
What this trial is about
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.
Who can take part
Age range
6 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 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.
Exclusion criteria
- 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.
Where it is running
1 location listed across 1 US state.
- CCM Clinical Research Group - Miami, Florida, United States