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A Study to Determine Effective and Tolerable Titration Scheme for OROS-Methylphenidate in Children With Attention-deficit Hyperactivity Disorder

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier:
NCT00518232
First received: August 16, 2007
Last updated: April 26, 2010
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
 Drug: OROS-methylphenidate
 Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Taiwan Ltd:

Primary Outcome Measures:
  • 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))

Secondary Outcome Measures:
  • 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.

Enrollment: 520
Study Start Date: September 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who used to be treated their Attention-deficit hyperactivity disorder with IR-MPH less than 70 mg/day (inclusive) for at least one month without severe adverse events or possible contraindications with MPH
  • Patients must be living with the parent/caregiver who can complete the questionnaires during the study
  • Patients or parent/caregiver without any psychotic disease or any mental situation which may cause the concern to properly complete the questionnaires

Exclusion Criteria:

  • Known to be non-responders to methylphenidate
  • Marked anxiety, tension, aggression/agitation
  • Known or suspected mental retardation or significant learning disorder
  • Glaucoma, ongoing seizure disorder, psychotic disorder, diagnosis or family history of Tourette's disorder, bipolar disorder, eating disorder
  • Subject who require drug therapy or hospitalization for treatment of a mood or anxiety disorder
  • other psychotropic medication subject is taking at study entry could be continued during study period they were maintained at a stable dose for a minimum of 4 weeks pre-study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518232

Sponsors and Collaborators
Johnson & Johnson Taiwan Ltd
Investigators
Study Director: Johnson & Johnson Taiwan, Ltd. Clinical Trial Johnson & Johnson Taiwan Ltd
  More Information

No publications provided

Responsible Party: Medical Director, Johnson & Johnson Taiwan, Ltd.
ClinicalTrials.gov Identifier: NCT00518232     History of Changes
Other Study ID Numbers: CR012508
Study First Received: August 16, 2007
Last Updated: April 26, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Johnson & Johnson Taiwan Ltd:
Methylphenidate
Attention Deficit Hyperactivity Disorder

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
 Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013