Efficacy of Atomoxetine in the Neuropsychological Tests Among Children With ADHD
|First Received Date ICMJE||September 13, 2007|
|Last Updated Date||May 16, 2012|
|Start Date ICMJE||July 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00529893 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Efficacy of Atomoxetine in the Neuropsychological Tests Among Children With ADHD|
|Official Title ICMJE||Efficacy of Atomoxetine in the Neuropsychological Tests Among Children With ADHD|
The purpose of this study is examine the efficacy of atomoxetine on executive functioning measures including the Continuous Performance Test (CPT) and the executive function measures of the Cambridge Automated Neuropsychological Test Automated Battery (CANTAB).
The rationale of this proposal is based upon the high prevalence (7.5% in Taiwan (Gau et al., 2004b)), the magnitude of the short- and long-term impact on individuals, family, and society, the responsibility of attention-deficit hyperactivity disorder ADHD to treatments with CNS stimulants and Atomoxetine. Although numerous studies have shown that methylphenidate demonstrates significant effect on improving neuropsychological functioning including inhibition of executive function (e.g., Aron et al., 2003; Kempton et al., 1999; Konrad et al., 2004) and motor control measures (e.g., Moll et al., 2000), there has been no study examining the effect of Atomoxetine on the improvement of response inhibition or other neuropsychological functioning among children with ADHD. As several clinical trials have shown the efficacy of Atomoxetine in improving the core symptoms of ADHD (e.g., Eiland and Guest, 2004; Michelson et al., 2002) and Atomoxetine has been approved by FDA as first line medication for child and adult ADHD in 2002, we anticipate that Atomoxetine will demonstrate significant efficacy on treating ADHD by improvement of neuropsychological measures.
The objectives of this study are:
This study is an open label, non randomized, clinical trial with daily dose of atomoxetine 1.2 mg/kg for subjects with ADHD. Thirty drug-naïve children with DSM-IV ADHD and 30 normal children matched in sex, age, and IQ will be recruited. All of the participants will be assessed by the CPT, WSCT, CANTAB, and several measures covering domains of ADHD symptoms and social functioning. Subjects with ADHD will be reassessed using the neuropsychological tests and other measures on Week 4 (Visit 2) 3 days, Week 12 (Visit 2) 3 days of treatment with atomoxetine 1.2 mg/kg.
The sample will consist of 30 subjects with ADHD, aged 10 to 15, and 30 subjects without ADHD, who are matched in age, sex, and IQ as cases. We anticipate that this study will provide enough evidence to support the efficacy of Atomoxetine not only on the symptoms improvement but also neuropsychological measures and fMRI studies among children with ADHD.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Case-Only|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
Subjects are diagnosed as DSM-IV, Attention Deficit Hyperactivity Disorder (ADHD).
|Condition ICMJE||Attention Deficit Disorder With Hyperactivity|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Gau SS, Shang CY. Improvement of executive functions in boys with attention deficit hyperactivity disorder: an open-label follow-up study with once-daily atomoxetine. Int J Neuropsychopharmacol. 2010 Mar;13(2):243-56. Epub 2009 Oct 23.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||July 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
(1) subjects had the clinical diagnosis and the K-SADS-E of DSM-IV ADHD; (2) their ages range from 10 to 15; (3) subjects must not have taken any medication used to treat ADHD; (4) subjects' IQ should be larger than 80; (5) subjects and their parents and teachers consent to participate and have the ability to complete self-administered measures in this study.
The subjects will be excluded from the study if they currently meet criteria or have a history of the following conditions as defined by DSM-IV: Shizophrenia, Schizoaffective Disorder, Organic Psychosis, Mental Retardation, Pervasive Developmental Disorder, Anxiety Disorders, Phobia, Obsessive-Compulsive Disorder, Depressive Disorders, or Bipolar Disorders. In addition, subjects will be excluded from this study if any evidence showing medical problems, or seizure. Moreover, the subjects will be excluded from the control group if have a history of the following condition as defined by DSM-IV: ADHD, ODD, or CD in addition to the above exclusion criteria.
|Ages||10 Years to 15 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Taiwan|
|NCT Number ICMJE||NCT00529893|
|Other Study ID Numbers ICMJE||200612093M|
|Has Data Monitoring Committee||Yes|
|Responsible Party||National Taiwan University Hospital|
|Study Sponsor ICMJE||National Taiwan University Hospital|
|Collaborators ICMJE||Eli Lilly and Company|
|Information Provided By||National Taiwan University Hospital|
|Verification Date||April 2012|
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