Attention Deficit Disorder With Hyperactivity study: Concerta vs Digital therapeutics
Official title Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of ADHD in Children.
ClinicalTrials.gov ID: NCT06369714
What this study is testing
What is Concerta?
an investigational extended-release tablet being studied as a potential treatment for attention deficit hyperactivity disorder (ADHD) in children. is designed to increase dopamine and norepinephrine activity in the brain, which may help improve attention and reduce hyperactivity.
Also referred to as Methylphenidate Hydrochloride.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to know whether a digital neurofeedback and executive‑function game can improve attention and executive skills in kids with ADHD, either by itself or together with medication.
- Who it's for
- Children ages 6 to 12 who have been diagnosed with attention‑deficit/hyperactivity disorder.
- What's involved
- Participants will use an iPad game at home for 30‑minute sessions, 30 times over 8 weeks. Depending on the group, they may also take their usual ADHD medicine. Parents will fill out questionnaires about the experience.
- Time commitment
- The trial lasts about 8 weeks and includes 30 half‑hour game sessions plus a few clinic visits for assessments.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 12
You may be able to join if
- Meet the diagnostic criteria established by the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) for ADHD.
- Digital Cancellation Test total score\<50 points.
- Raven's Standard Progressive Matrices score≥85.
- 6 years ≤ Age\<12 years.
- No interventions for ADHD received within 4 weeks.
You likely can't join if
- Patients with organic mental disorders, schizophrenia, bipolar disorder, depressive disorders, and other psychiatric conditions.
- Patients with comorbid autism spectrum disorder, Tourette's syndrome, and other neurodevelopmental disorders.
- Patients with comorbid conduct disorders.
- Patients with severe traumatic brain injury or neurological disorders.
- Patients with a history of severe somatic diseases.
- Patients with a history of substance or drug dependency.
See the full eligibility criteria
- Meet the diagnostic criteria established by the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) for ADHD.
- Digital Cancellation Test total score\<50 points.
- Raven's Standard Progressive Matrices score≥85.
- 6 years ≤ Age\<12 years.
- No interventions for ADHD received within 4 weeks.
- No color blindness.
- Patients with organic mental disorders, schizophrenia, bipolar disorder, depressive disorders, and other psychiatric conditions.
- Patients with comorbid autism spectrum disorder, Tourette's syndrome, and other neurodevelopmental disorders.
- Patients with comorbid conduct disorders.
- Patients with severe traumatic brain injury or neurological disorders.
- Patients with a history of severe somatic diseases.
- Patients with a history of substance or drug dependency.
The study team makes the final eligibility decision.
Where it is enrolling
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.