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

Mahidol University78 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Adhd

Interventions

prolong-release methylphenidateDRUG

This randomization, cross-over design study will enroll subjects who receive a stable dose of immediate-release methylphenidate (IR-MPH) for at least 4 weeks. Eligible subjects will be switching from IR-MPH to the first brand prolong-release methylphenidate (PR-MPH) for 4 weeks and switching to another brand for 4 weeks. The study consists of 3 parts: screening, study period, and post-treatment follow-up. The duration of this study will be 8 weeks with 2 visits during the study period. The primary outcome is the efficacy of treatment will be evaluated by SNAP-IV.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The change from baseline in parent Swansan, Nolan and Pelham version IV (SNAP-IV) parent rating score

SNAP-IV,26 items score, included 18-items that reflect ADHD symptoms and 8-items that reflect oppositional defiant disorder symptoms

Time frame: baseline, 4 and 8 week

Secondary Outcomes

The change from baseline in Clinical Global Impression-Severity (CGI-S) scale

CGI-S scale is measured the severity of symptoms by physician, rated from 1 (normal) to 7 (among the most severely ill patients)

Time frame: baseline, 4 and 8 week

The difference in discontinuation rate between two groups of treatment

Discontinuation rate is a proportion of patients who discontinue medication from any reason

Time frame: 4 and 8 week

The difference in adverse events rate between two groups of treatment

adverse events rate is a proportion of patients who have the adverse events

Time frame: baseline, 4 and 8 week

Central Contacts

Chanatthida Muangkum

CONTACT

6654419935 chanatt.mua@gmail.com

Data from ClinicalTrials.gov

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