A Study to Determine Effective and Tolerable Titration Scheme for OROS-Methylphenidate in Children With Attention-deficit Hyperactivity Disorder
The purpose of the study is to investigate the clinical benefit of switching children with ADHD from immediate-release methylphenidate (IR-MPH) to OROS-methylphenidate under the correct dosage conversion scheme.
Attention Deficit Hyperactivity Disorder
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effective and Tolerable Titration Scheme and Dosage in Children With Attention-deficit Hyperactivity Disorder Treated With OROS-Methylphenidate|
- To investigate the final dosage of OROS-methylphenidate for patients achieving optimal response in 10 weeks.The optimal response is defined as a score of 0 or 1 on each of the first 18 ADHD items (referred to SNAP-IV (Swanson, Nolan and Pelham))
- To describe the measurement of symptom(s)/sign(s) quality of life improvement and to describe the efficacy and the global assessment of satisfaction by parents/caregivers and patients at every visit throughout the study in 10 weeks.
|Study Start Date:||September 2006|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
This is a prospective, non-comparative study. Each patient will be treated for 10 weeks including 6-week titration phase and 4-week maintenance phase. After an initial baseline evaluation, patients currently receiving IR-Methylphenidate (IR-MPH) therapy will switch to receiving OROS-methylphenidate once daily. Patients receiving IR-MPH =15 mg per day will switch to receive 18 mg once daily OROS-methylphenidate. For patients on IR-MPH daily dosage >15 mg and =30 mg, the initial dose of OROS-methylphenidate will be 36 mg once daily. Other patients receiving IR-MPH higher than 30 mg per day, will switch to receive 54 mg once daily OROS-methylphenidate. During the 6-week titration phase, those patients who do not achieve the criteria of "Optimal Response" will be titrated by biweekly increase to next dose level (36 mg per day, and then 54 mg per day). The maximum dose of OROS-methylphenidate per day is 54 mg as package insert indicates. However, dose decreases are allowed if clinically intolerable adverse events emerge. At the end of 6-week titration phase, the final titration dose should be maintained for the last 4 weeks of the trial regardless of the optimal response. In summary, all patients will attend bi-weekly clinic visits for the first 6 weeks (visit 2 to 4) and monthly clinic visits for the subsequent 4 weeks (visit 5). Patients will receive 18 mg or 36mg or 54 mg once daily OROS-methylphenidate for 10 weeks.