An Effectiveness and Safety Study of CONCERTA* vs. Immediate Release Methylphenidate (IR MPH) in Attention Deficit Hyperactivity Disorder Children - Full Text View

Sponsor:	Janssen-Ortho Inc., Canada
Information provided by:	Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier:	NCT00304681

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

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

Detailed Description:

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
Genders Eligible for Study:	Both
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

Contacts and Locations

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:

A Randomized, Controlled, Effectiveness Trial of OROS-Methylphenidate compared to Usual Care with Immediate-Release-Methylphenidate in Attention-Deficit-Hyperactivity-Disorder This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Steele M, Weiss M, Swanson J, Wang J, Prinzo RS, Binder CE. A randomized, controlled effectiveness trial of OROS-methylphenidate compared to usual care with immediate-release methylphenidate in attention deficit-hyperactivity disorder. Can J Clin Pharmacol. 2006 Winter;13(1):e50-62. Epub 2006 Jan 23.

ClinicalTrials.gov Identifier:	NCT00304681 History of Changes
Other Study ID Numbers:	CR003112
Study First Received:	March 17, 2006
Last Updated:	May 16, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Janssen-Ortho Inc., Canada:

Attention Deficit Hyperactivity Disorder
OROS* Methylphenidate

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 February 09, 2012