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

Not Applicable

• Conditions: Adhd
• Interventions: Drug: prolong-release methylphenidate

• Registration Number: NCT05410626
• Lead Sponsor: Mahidol University

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 methylphenidate treatment

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 weeks. Swanson, Nolan and Pelham parent rating scale is used to measure the primary outcome.

Study Timeline

• Status Verified: 2022-06
• Study Start: 2022-06-01
• Study First Submitted: 2022-06-05
• Study First Submitted QC: 2022-06-05
• Last Update Submitted: 2022-06-05
• Study First Posted: 2022-06-08
• Last Update Posted: 2022-06-08
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
original	prolong-release methylphenidate	This study use 18 and 36 mg of original prolong-release methylphenidate. Dosing of Medication is equivalent to immediate-release. Medication administration is once daily in the morning.
generic	prolong-release methylphenidate	This study use 18 and 36 mg of generic prolong-release methylphenidate. Dosing of Medication is equivalent to immediate-release. Medication administration is once daily in the morning.

Primary Outcome Measures

Name	Time	Method
The change from baseline in parent Swansan, Nolan and Pelham version IV (SNAP-IV) parent rating score	baseline, 4 and 8 week	SNAP-IV,26 items score, included 18-items that reflect ADHD symptoms and 8-items that reflect oppositional defiant disorder symptoms

Secondary Outcome Measures

Name	Time	Method
The change from baseline in Clinical Global Impression-Severity (CGI-S) scale	baseline, 4 and 8 week	CGI-S scale is measured the severity of symptoms by physician, rated from 1 (normal) to 7 (among the most severely ill patients)
The difference in discontinuation rate between two groups of treatment	4 and 8 week	Discontinuation rate is a proportion of patients who discontinue medication from any reason
The difference in adverse events rate between two groups of treatment	baseline, 4 and 8 week	adverse events rate is a proportion of patients who have the adverse events