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Trial record 1 of 1 for:    NCT00866996
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Community-based Study Comparing Extended-release Methylphenidate and Atomoxetine in Children With Attention-deficit Hyperactivity Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00866996
Recruitment Status : Completed
First Posted : March 23, 2009
Last Update Posted : May 24, 2011
Information provided by:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Brief Summary:
The purpose of this study was to better understand the treatment outcomes of extended-release methylphenidate and atomoxetine in children with attention-deficit hyperactivity disorder (ADHD) as evaluated by physicians and parents in a community setting.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Methylphenidate extended-release; Atomoxetine Phase 4

Detailed Description:
Methylphenidate and atomoxetine are available for the treatment of ADHD in children. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monamines into the extraneuronal space. The mechanism by which atomoxetine produces its therapeutic effect is thought to be related to selective inhibition of the presynaptic norephinephrine transporter. This was a multi-center, randomized, open-labeled, parallel design study of extended-release methylphenidate and atomoxetine in children aged 6 to 12 years with ADHD as evaluated by physicians and parents. Children were randomly assigned (2:1, respectively) to 3 weeks of treatment with extended-release methylphenidate or atomoxetine. Physicians evaluated treatment using the ADHD Rating Scale (ADHD-RS) and the Clinical Global Impression-Improvement of Illness scale (CGI-I). Assessments were made prior to beginning treatment (screening), at a telephone interview 1 week after beginning treatment, at a clinic visit 2 weeks after beginning treatment, and at the final clinic visit (3 weeks). Parents assessed treatment using the Parent Satisfaction Questionnaire (PSQ) from treatment days 2 to 13 and at the clinical visit 3 weeks after beginning treatment. The questions of interest included whether there is a difference between treatment in the improvement of behavior and the timing of such differences. Vital signs, height, and weight were also recorded as were adverse events. Study drug was to be taken orally once each day. Patients randomly assigned to extended-release methylphenidate began treatment with 18 mg/day. Patients randomly assigned to atomoxetine began treatment with 0.5 mg/kg/day. The study medication was to be titrated as considered appropriate by the patient's physician. The duration of treatment was 21 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1323 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center Randomized Parallel Group Study Evaluating Treatment Outcomes of Concerta (Extended Release Methylphenidate) and Strattera (Atomoxetine) in Children With Attention-deficit/Hyperactivity Disorder
Actual Study Completion Date : December 2003

Primary Outcome Measures :
  1. Observed and change from baseline measures for ADHD-RS total scores will be summarized by descriptive statistics and analyzed by repeated measures of analysis of covariance.

Secondary Outcome Measures :
  1. CGI-I and each PSQ item separately were summarized by descriptive statistics and frequency distributions. Treatment effects were tested by chi-square statistics. Onset of effect was assessed by PSQ on Days 2 to 13.

Information from the National Library of Medicine

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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 who met the DSM-IV criteria for a primary diagnosis of ADHD of any subtype (may have been newly diagnosed with ADHD and not on treatment)
  • score of 24 or higher on the ADHD Rating Scale (ADHD-RS) at screening
  • physician must have rated the patient as "Moderately ill" or worse on the CGI-S at screening
  • children may have been enrolled who were not receiving adequate treatment for ADHD (based on clinical judgment in consultation with the parent)
  • children must have been washed-out of their current treatment a minimum of 3 days or 5 half lives of the medication whichever was longer
  • and the child and parent must have given written informed consent, and assent, where applicable.

Exclusion Criteria:

  • Female child who had experienced menarche
  • presence of eating or substance disorder or co-morbid psychiatric condition other than oppositional defiant disorder
  • history of seizure, tic disorder, mental retardation, severe developmental disorder (i.e. severe cerebral palsy, autism) or family history of Tourette's Disorder
  • required medications as excluded by the package inserts for Concerta or Strattera
  • diagnosed with hyperthyroidism or glaucoma
  • and known non-responders to treatments indicated for ADHD.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00866996

Sponsors and Collaborators
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
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Study Director: McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Additional Information:
Publications of Results:
Layout table for additonal information Identifier: NCT00866996    
Other Study ID Numbers: CR008329
First Posted: March 23, 2009    Key Record Dates
Last Update Posted: May 24, 2011
Last Verified: March 2010
Keywords provided by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.:
Attention deficit hyperactivity disorder
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Atomoxetine Hydrochloride
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
Adrenergic Uptake Inhibitors
Adrenergic Agents