A Study to Determine Effective and Tolerable Titration Scheme for OROS-Methylphenidate in Children With Attention-deficit Hyperactivity Disorder
The Effective and Tolerable Titration Scheme and Dosage in Children With Attention-deficit Hyperactivity Disorder Treated With OROS-Methylphenidate
1 other identifier
interventional
520
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2006
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 16, 2007
CompletedFirst Posted
Study publicly available on registry
August 20, 2007
CompletedApril 28, 2010
April 1, 2010
9 months
August 16, 2007
April 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Taiwan, Ltd. Clinical Trial
Johnson & Johnson Taiwan Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 16, 2007
First Posted
August 20, 2007
Study Start
September 1, 2006
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
April 28, 2010
Record last verified: 2010-04