An Effectiveness and Safety Study of CONCERTA* vs. Immediate Release Methylphenidate (IR MPH) in Attention Deficit Hyperactivity Disorder Children
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| ClinicalTrials.gov Identifier: NCT00304681 |
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Recruitment Status :
Completed
First Posted : March 20, 2006
Last Update Posted : May 17, 2011
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Attention Deficit Hyperactivity Disorder | Drug: OROS*-Methylphenidate | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 147 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Actual Study Completion Date : | February 2004 |
- 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
- 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
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| Ages Eligible for Study: | 6 Years to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304681
| Study Director: | Janssen-Ortho Inc. Clinical Trial | Janssen-Ortho Inc., Canada |
Additional Information:
Publications of Results:
| ClinicalTrials.gov Identifier: | NCT00304681 History of Changes |
| Other Study ID Numbers: |
CR003112 |
| First Posted: | March 20, 2006 Key Record Dates |
| Last Update Posted: | May 17, 2011 |
| Last Verified: | April 2010 |
Keywords provided by Janssen-Ortho Inc., Canada:
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Attention Deficit Hyperactivity Disorder OROS* Methylphenidate |
Additional relevant MeSH terms:
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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 |