Attention deficit hyperactivity disorder
Conditions
Interventions
Medicine group:Guanfaxin hydrochloride sustained-release tablets, specifications: 1mg, 2mg, 3mg, 4mg, batch numbers: 1mg-CTM23009, 2mg-CTM23002, 3mg-CTM23003, 4mg-CTM23004
Manufacturer: Yichang Renfu Pharmaceutical Co., Ltd
Placebo group:Guanidine hydrochloride sustained-release tablet simulant, specifications: 1mg, 2mg, 3mg, 4mg, batch numbers: 1mg-CTM23005, 2mg-CTM23006, 3mg-CTM23014, 4mg-CTM23015
Sponsors
Beijing Anding Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 17 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. From 6 years old to 17 years old, regardless of gender; 2. Weight >= 17kg; 3. Meets the diagnostic criteria for Attention Deficit Hyperactivity Disorder (ADHD) in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), and has been evaluated using the K-SADS-PL (Clinical Diagnosis) questionnaire for emotional disorders and schizophrenia in school-age children to confirm the clinical diagnosis; 4. Attention Deficit Hyperactivity Disorder Rating Scale Version 4 (ADHD-RS-IV) parental score, with a total score of >= 25 for male subjects and >= 22 for female subjects; 5. Clinical General Impression Scale Disease Severity Scale (CGI-S) score >= 4 points; 6. Both the subjects and guardians agree to participate in this trial and sign the informed consent form (guardians must sign the guardian version of the informed consent form, children over 8 years old should sign the minor version of the informed consent form, and children under 8 years old should be informed).
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. The subject or guardian cannot fully understand the Chinese instructions; 2. Subjects who are allergic to guanidine derivatives or other components of this product; 3. Hypotension (6-9 years old: systolic blood pressure= 10 years: systolic blood pressure140; >6-12 years: heart rate>130 beats/minute; >12-18 years: heart rate>110 beats/minute); 4. Subjects with QTc interval (Fridericia correction) >= 430ms; 5. Subjects with severe liver and kidney diseases (ALT, AST >= 1.5 times the upper limit of normal values, or serum creatinine >upper limit of normal values); 6. Subjects with a history of diseases or surgeries that may increase safety risks, such as congenital heart disease or cardiac surgery, cardiovascular and cerebrovascular diseases (such as hypertension, angina, cerebral aneurysms, etc.), known cardiac structural abnormalities, severe arrhythmias, cardiac conduction problems (such as clinically significant heart block), exercise related cardiac events (such as syncope or threatened syncope), thyroid dysfunction, etc; 7. Subjects with other psychiatric disorders (excluding oppositional defiant disorder (ODD)), such as anxiety, depression, mental retardation, personality disorders, epilepsy, tic disorders, intellectual disabilities, etc; 8. Subjects who have a history of suicide/self injury, exhibit suicidal ideation, or have been determined by researchers to be at risk of suicide; 9. Subjects with known sudden cardiac death, ventricular arrhythmia or extended QT/QTc interval family history (parents, brothers and sisters) 10. Within 14 days prior to the experiment, have taken medication related to ADHD or have central nervous system effects or may be delayed Subjects with long QT/QTc intervals, drugs that affect cognitive ability, blood pressure, and heart rate; 11. Subjects with a history of alcohol or drug abuse within the past 6 months; 12. Subjects who have participated in drug clinical trials within the past 3 months; 13. Subjects who are unable to cooperate (including those who cannot swallow tablet formulations); 14. Participants who are deemed unsuitable by the researchers to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADHD Rating Scale Fourth Edition (ADHD-RS-IV) Parent Total Score Change Value; | — |
Secondary
| Measure | Time frame |
|---|---|
| Conners Parent Rating Scale Total Score Change;Percentage of subjects with CGI-S scores of 1 or 2 at the end of the two dose maintenance periods;Percentage of subjects with CGI-I scores of 1 or 2 at the end of the two dose maintenance periods;Proportion of subjects with a change rate of >= 50% (or 40%) in the total parental score of ADHD-RS-IV at the end of the dose maintenance period compared to baseline in both groups;Changes in WFIRS parental review scores from baseline at the end of dose maintenance period;Changes in inattentive scores (Items 1-9) of ADHD-RS-IV at the End of Dose Maintenance Period Compared to Baseline;Changes in hyperactive/impulsivitive scores (Items 10-18) of ADHD-RS-IV at the End of Dose Maintenance Period Compared to Baseline; | — |
Countries
China
Contacts
Public ContactYi Zheng
Beijing Anding Hospital Affiliated to Capital Medical University
Outcome results
None listed