Status:
UNKNOWN
The Study of Efficacy and Safety of Generic Methylphenidate Prolong-released Comparison With Original
Lead Sponsor:
Mahidol University
Conditions:
Adhd
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief 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 ...
Detailed Description
This 4 weeks cross-over study will recruit 78 children, aged 6 to 12 years, with ADHD. They will be randomized to receive generic or original PR-MPH for 4 weeks and then switch to another brand for 4 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2022
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05410626
Start Date
June 1 2022
End Date
August 31 2022
Last Update
June 8 2022
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