Attention-Deficit/Hyperactivity Disorder (ADHD)
Conditions
Interventions
Oral treatment with Methylphenidate Hydrochloride Extended-Release Tablets Group:None
Sponsors
West China Second University Hospital of Sichuan University (WCSUH- SCU)
Eligibility
Sex/Gender
All
Age
6 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1.Children and adolescents aged 6-17 years, regardless of gender; 2.Meet the diagnostic criteria for ADHD (any subtype) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V); 3.Wechsler Intelligence Scale for Children (WISC) score =80; 4.The parent completing the questionnaires has normal understanding and expression ability and is the primary caregiver of the child; 5.Participants are treatment-naïve or have discontinued ADHD medication for at least 7 days; 6.Understand and voluntarily participate in the study; written informed consent signed by the child and/or parent/legal guardian;
Exclusion criteria
Exclusion criteria: 1.Contraindications to stimulants (e.g., symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism); 2.History of seizures or abnormal electroencephalogram (EEG) with epileptiform discharges; 3.Comorbid bipolar disorder, psychotic disorder, anxiety disorder, depressive disorder, tic disorder, or pervasive developmental disorder; 4.History of allergy to methylphenidate hydrochloride or any component of the formulation; 5.Known hypersensitivity to methylphenidate, or previous failure to respond to or intolerance of an adequate trial of methylphenidate; 6.Patients considered by the investigator to be unsuitable for participation in the clinical trial or unable to complete the study for any other reason;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse drug reactions;Swanson, Nolan, and Pelham-IV (SNAP-IV) scale score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Methylphenidate Plasma Concentration;Electroencephalography (EEG) data;Behavior Rating Inventory of Executive Function (BRIEF) score;ADHD symptom remission rate;Clinical Global Impression-Improvement (CGI-I) score; | — |
Countries
China
Contacts
Public ContactLuo Rong
West China Second University Hospital of Sichuan University (WCSUH- SCU)
Outcome results
None listed