Attention Deficit Hyperactivity Disorder (ADHD)
Conditions
Interventions
Patients with Attention Deficit Hyperactivity Disorder:Receive treatment with central nervous system stimulants and use Clonidine Hydrochloride Sustained-release Tablets in combination based on clinic
Sponsors
Shanghai Children's Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Both parents (legal representatives) and the patient agree to participate in the study. Either one or both parents (legal representatives) and the patient shall sign the informed consent form (patients under 8 years old are not required to sign the informed consent form and will only receive information disclosure); 2. Meeting the diagnostic criteria for Attention Deficit Hyperactivity Disorder (ADHD) specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 3. ADHD patients who plan to receive or are currently receiving monotherapy with central stimulants (including patients with insufficient response or intolerance to stimulants); 4. No restriction on gender, with an age range of 6 to 17 years old (inclusive).
Exclusion criteria
Exclusion criteria: 1. Patients with a history of mental disorders who require antipsychotic medication, or those suffering from severe mental disorders deemed by the investigator to interfere with the study results; 2. Individuals allergic to clonidine and its excipients; 3. Patients who have used clonidine-class drugs within 30 days prior to screening; 4. Those with a history of alcohol or drug abuse and addiction; 5. Pregnant and lactating women; 6. Persons judged by the investigator to be ineligible for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Total Score of SNAP-IV (Physician Version) compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| SNAP-IV (Swanson, Nolan and Pelham Rating Scale)(Physician Version) Subscale Scoring;12-lead electrocardiogram;Adverse events;Total Score of SNAP-IV (Physician Version);Liver and kidney function (ALT, AST, total bilirubin, direct bilirubin, creatinine, urea, uric acid);Total score of the Strengths and Difficulties Questionnaire;Combined medication;Total score of the Children's Sleep Habits Questionnaire; | — |
Countries
China
Contacts
Public ContactJinjin Chen
Shanghai Children's Hospital
Outcome results
None listed