The Study of Efficacy and Safety of Generic Methylphenidate Prolong-released Comparison With Original

• Status: Not yet recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is a cross-over trial, design to determine the efficacy and safety of generic and original prolong-release methylphenidate (PR-MPH) in children with ADHD who had received immediate-release methylphenidate treatment

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• Ages 6 to 12 years

• Diagnosis of ADHD according to DSM-5 of ICD-10

• Patient who receiving a stable dose of IR-MPH for at least 4 weeks before screening

• Patient who has a stable clinical symptoms.

• Patients or their legal representatives provide informed consent prior to enrollment

Exclusion Criteria:

• Patients who present of a serious obstructive gastrointestinal disease

• Patients cannot swallow the whole tablet

• Patients with depression, schizophrenia, bipolar disorder, and 1-month substance use prior to study

• Patients who present of an unstable co-morbidity: anxiety, seizure, conduct disorder and oppositional defiant disorder

• Patients or patients' family have a history of poor compliance

• Patients who receiving monoamine oxidase inhibitors antidepressant or stop taking not more than 14 days

• Patients who receiving PR-MPH except stop taking more than 7 days

• Patients' parent has a family problem and currently treatment with family therapy or adjust medication