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Sponsored by: |
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
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Information provided by: | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
ClinicalTrials.gov Identifier: | NCT00866996 |
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 | Intervention | Phase |
---|---|---|
Attention Deficit Hyperactivity Disorder |
Drug: Methylphenidate extended-release; Atomoxetine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 6000 |
Study Completion Date: | December 2003 |
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.
Ages Eligible for Study: | 6 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | McNeil Consumer & Specialty Pharmaceuticals Clinical Trial | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
Study ID Numbers: | CR008329 |
Study First Received: | March 19, 2009 |
Last Updated: | March 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00866996 History of Changes |
Health Authority: | United States: Institutional Review Board |
Methylphenidate Concerta Atomoxetine Attention deficit hyperactivity disorder |
Dopamine Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Attention Deficit and Disruptive Behavior Disorders Methylphenidate Atomoxetine Central Nervous System Stimulants Dyskinesias |
Signs and Symptoms Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations Dopamine Agents |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Atomoxetine Methylphenidate Signs and Symptoms Pathologic Processes Attention Deficit Disorder with Hyperactivity Mental Disorders |
Therapeutic Uses Mental Disorders Diagnosed in Childhood Hyperkinesis Disease Nervous System Diseases Attention Deficit and Disruptive Behavior Disorders Central Nervous System Stimulants Dyskinesias Pharmacologic Actions Neurologic Manifestations Dopamine Agents Central Nervous System Agents |