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| Descriptive Information Fields | |||||
| Brief Title † | Comparison of Atomoxetine and Placebo in Children With ADHD and/or Reading Disorder | ||||
| Official Title † | A Randomized, Double-Blind, Crossover Comparison of Atomoxetine and Placebo in Child Outpatients With Attention-Deficit/Hyperactivity Disorder, Reading Disorder, or Comorbid Attention-Deficit/Hyperactivity Disorder and Reading Disorder. | ||||
| Brief Summary | To test the hypothesis that a 4 week treatment with atomoxetine is more effective than placebo in patients with combined type ADHD, patients with only Reading Disorder, and patients with combined type ADHD and Reading Disorder. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Stop Signal Reaction Time (SSRT) as derived from the Stop Signal Reaction Time Paradigm. [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | In subset of patients 10 years or older, compare performance on SSRT and a phonological task. [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ] Compare performance between groups on SSRT and lexical decision task. [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ] Compare brain functioning using magnetoelectroencephalogram (MEG)on SSRT and a phonological and lexical decision task. [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ] Compare results on SSRT and a phonological and lexical decision task using MEG in patients with ADHD-Combined Type and normal controls. [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ] Working memory by Corsi Block Tapping Test (CBTT) [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ] Attention Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ] Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ] Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale [ Time Frame: over 4 weeks of therapy ] [ Designated as safety issue: No ] Adverse Events (AEs) [ Time Frame: over 6 weeks ] [ Designated as safety issue: Yes ] |
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| Condition † | Attention Deficit Hyperactivity Disorder Reading Disorder |
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| Intervention † | Drug: Atomoxetine Hydrochloride Drug: placebo |
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| MEDLINE PMIDs | |||||
| Links | Lilly Clinical Trial Registry  |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 76 | ||||
| Start Date † | April 2005 | ||||
| Completion Date | December 2007 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 8 Years to 12 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | Belgium, Netherlands | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00191906 | ||||
| Organization ID | 7955 | ||||
| Secondary IDs †† | B4Z-MC-LYCK | ||||
| Study Sponsor † | Eli Lilly and Company | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Eli Lilly and Company | ||||
| Verification Date | September 2008 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | September 19, 2008 | ||||
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