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A multicenter real-world study on the improvement effects of Liyoujia® and Concerta® on clinical symptoms and executive function in children with attention deficit hyperactivity disorder (ADHD)

A multicenter real-world study on the improvement effects of Liyoujia® and Concerta® on clinical symptoms and executive function in children with attention deficit hyperactivity disorder (ADHD)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113487
Enrollment
Unknown
Registered
2025-11-28
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention deficit hyperactivity disorder

Interventions

Group Concetra:Take Methylphenidate Hydrochloride Extended-release Tablets (trade name: Concetra?), with a dosage of 18mg. Film
Group liyoujia:Take the sustained-release tablets of methylphenidate hydrochloride (trade name: Liyoujia?), with a dosage of 18mg per tablet.

Sponsors

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 16 Years

Inclusion criteria

Inclusion criteria: 1.The subjects are children and adolescents aged 7 to 16 years old, with no gender restrictions. 2. All patients meet the diagnostic criteria for ADHD (any subtype) according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), confirmed through clinical history collection and structured interviews. 3. Subjects are either drug-naive or have discontinued medication for >= 6 months. For ethical reasons, individuals who previously showed no response to or could not tolerate adequate doses of methylphenidate are excluded.

Exclusion criteria

Exclusion criteria: 1) Medical contraindications for doping (such as angle-closure glaucoma, cardiovascular diseases); 2) History of epileptic seizures or abnormal EEG with epileptiform discharges; 3) Bipolar disorder, psychotic disorders, anxiety disorders, depressive disorders, tic disorders, pervasive developmental disorders; 4) Intelligence quotient (IQ) <70 as measured by the Wechsler Intelligence Scale for Children (WISC-R); 5) History of allergy to methylphenidate hydrochloride or any component of the drug; hypersensitivity to methylphenidate or previous ineffectiveness or intolerance to adequate doses of methylphenidate; history of allergy to one or more drugs, foods, etc.; 6) Subjects deemed by the investigator as unsuitable for participation in clinical trials or unable to complete the study for other reasons.

Design outcomes

Primary

MeasureTime frame
Total score of the Fourth Edition of the ADHD Rating Scale (SNAP-IV);

Secondary

MeasureTime frame
Weiss Functional Deficit Scale (Parent Version, WFIRS-P);BRIEF Executive Function Questionnaire Score;

Countries

China

Contacts

Public Contactjinzhijuan

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine

syjzj714@hotmail.com+86 21 3862 6920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026