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An Effectiveness and Safety Study of CONCERTA* vs. Immediate Release Methylphenidate (IR MPH) in Attention Deficit Hyperactivity Disorder Children
This study has been completed.
Sponsor:
Janssen-Ortho Inc., Canada
Information provided by:
Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier:
NCT00304681
First received: March 17, 2006
Last updated: May 16, 2011
Last verified: April 2010
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Purpose
The purpose of this study is to determine the effectiveness and safety of OROS*methylphenidate/CONCERTA* vs. immediate release methylphenidate as a treatment for ADHD specifically for those children who have behavioural difficulties in the afternoon/after-school and evening periods.
| Condition | Intervention | Phase |
|---|---|---|
| Attention Deficit Hyperactivity Disorder | Drug: OROS*-Methylphenidate | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effectiveness of CONCERTA® vs. Usual Clinical Care With Immediate Release Methylphenidate (IR MPH) in Children (6-12 Years) With Attention Deficit Hyperactivity Disorder (ADHD): A Randomized, Open-Label Trial |
Resource links provided by NLM:
Further study details as provided by Janssen-Ortho Inc., Canada:
Primary Outcome Measures:
- Change in average SNAP-IV(Swanson, Nolan and Pelham -IV) score from baseline at end of study and the remission of symptoms between groups, defined as an average SNAP-IV score of <=1 at end of study
Secondary Outcome Measures:
- changes at end of study for Parenting Stress Index, Conners Parent Rating Scale, IOWA Conners Parent Rating Scale, Visual Analogue Scale for homework and social play, Resource Use Questionnaire, parent satisfaction, Clinical Global Impression
| Enrollment: | 147 |
| Study Completion Date: | February 2004 |
Methylphenidate, namely immediate release methylphenidate is the primary stimulant used in the treatment of children with Attention Deficit Hyperactivity Disorder (ADHD). Immediate release methylphenidate has limitations related to its time course of action.As the morning dose wears off, inattention may increase during late-morning classes. Similarly, when the midday dose is wearing off, the child may experience difficulty concentrating on homework. The second problem relates to compliance with midday and late afternoon dosing. Children feel stigmatized or embarrassed by trips to the nurse's office for medication and may skip doses as a result. In other cases, a school nurse may not be available or policies prohibit staff from administering drugs so children may be required to self-administer drug. CONCERTA® was developed to overcome these limitations. The purpose of this study is to see how effective and safe Concerta* is vs. immediate release methylphenidate in children with ADHD.
Patients will take either Concerta* (18, 27, 36, or 54 mg) or Immediate Release Methylphenidate tablets (maximum 60mg/day) orally every morning for 8 weeks.
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must be between 6 and 12 years of age inclusive, have a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) as defined by the DSM-IV established through clinical interview by the investigator and corroborated by the SNAP-IV parent rating scale, who in the opinion of the parents/caregivers exhibit significant after-school/evening behavioural difficulties where 12 hour coverage is desired
- Eligible patients will be evaluated after a minimum 3 day washout period without ADHD medication
- In addition, patients must also have a CGI-Severity score, at baseline of "moderate", "marked", "severe" or "extremely severe" in order to be eligible
- Patients could have had no prior treatment for ADHD or are presently taking something or could have had ADHD medication treatment in the past
Exclusion Criteria:
- No patients with marked anxiety, tension, aggression or agitation, glaucoma, an ongoing seizure disorder, a psychotic disorder, a diagnosis of Tourette's disorder, or a family history of Tourette's disorder, bipolar disorder, suspected mental retardation, significant learning disability, eating disorder or history of one, pre-existing gastrointestinal narrowing
- No patient with inability to swallow the medication whole, those with any unstable medical illness were excluded
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00304681
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304681
Sponsors and Collaborators
Janssen-Ortho Inc., Canada
Investigators
| Study Director: | Janssen-Ortho Inc. Clinical Trial | Janssen-Ortho Inc., Canada |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00304681 History of Changes |
| Other Study ID Numbers: |
CR003112 |
| Study First Received: | March 17, 2006 |
| Last Updated: | May 16, 2011 |
Keywords provided by Janssen-Ortho Inc., Canada:
|
Attention Deficit Hyperactivity Disorder OROS* Methylphenidate |
Additional relevant MeSH terms:
|
Disease Attention Deficit Disorder with Hyperactivity Hyperkinesis Pathologic Processes Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Methylphenidate Central Nervous System Stimulants Physiological Effects of Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on June 23, 2017