Multi-center, Single Blinded, RCT, Pivotal Study to Evaluate the Efficacy and Safety of DTx to Im… (NCT07173439) | Clinical Trial Compass
CompletedNot Applicable
Multi-center, Single Blinded, RCT, Pivotal Study to Evaluate the Efficacy and Safety of DTx to Improve ADHD
South Korea120 participantsStarted 2024-04-15
Plain-language summary
Background:
Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by inattention, hyperactivity, impulsivity, and impaired executive functioning. It typically begins in childhood and is often first diagnosed at school age due to learning and social behavioral difficulties. Therefore, ADHD treatment aims to directly enhance attention, reduce hyperactivity and impulsivity, and ultimately improve task performance and associated behavioral and relational issues.
Objective of the Clinical Trial:
To evaluate the safety of the investigational digital therapeutic device for the treatment of ADHD.
To evaluate the efficacy of the investigational digital therapeutic device for the treatment of ADHD.
Study Design \& Methodology:
A total of 122 participants were enrolled (62 in the treatment group and 60 in the control group), with 114 participants included in the Full Analysis Set (FAS: 58 treatment, 56 control).
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects must meet all the following inclusion criteria:
* Children and adolescents aged 6 years or older but under 13 years, both male and female.
* Diagnosed with ADHD according to DSM-5 criteria or ICD-10 diagnosis of ADHD (F90.0).
* K-ARS scores of 18 or higher for females and 22 or higher for males.
* No changes in ADHD medication dosage or regimen within 1 month prior to enrollment (\*For those receiving pharmacological treatment with methylphenidate or amphetamine-based products, a washout period of 14 days is required if they wish to participate after discontinuing medication).
* Medically healthy based on medical history and vital signs assessed during screening, without other medical abnormalities.
* Able to use a smartphone or tablet PC that meets specified requirements to operate the mobile application without difficulty.
* Both the subject and their guardian voluntarily agree to participate and provide written informed consent.
Exclusion Criteria:
* Subjects will be excluded if they meet any of the following criteria:
* Presence of any of the following psychiatric symptoms at baseline: chronic tic disorder (requiring medication), Tourette's disorder, or history of major obsessive-compulsive disorder, schizophrenia, bipolar disorder, post-traumatic stress disorder, conduct disorder, or other childhood psychosis (affective disorders are not exclusionary).
* Wechsler Intelligence Scale for Children (WISC) score below 80.
* Presence of congen…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in ADHD-RS (Investigator-Rated Scale) at end of treatment (FAS)
Timeframe: The digital therapy was administered over 4 weeks, including 6-7 visits (2-3 onsite, 4 phone). Screening and Baseline visits could occur on the same day. Final follow-up took place at week 4 post-treatment.