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Sponsors and Collaborators: |
National Taiwan University Hospital Eli Lilly and Company |
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Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00529893 |
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).
Condition |
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Attention Deficit Disorder With Hyperactivity |
Study Type: | Observational |
Study Design: | Case-Only |
Official Title: | Efficacy of Atomoxetine in the Neuropsychological Tests Among Children With ADHD |
Enrollment: | 30 |
Study Start Date: | July 2007 |
Study Completion Date: | July 2008 |
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.
Ages Eligible for Study: | 10 Years to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Subjects are diagnosed as DSM-IV, Attention Deficit Hyperactivity Disorder (ADHD).
Inclusion Criteria:
(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.
Exclusion Criteria:
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.
Taiwan | |
National Taiwan University Hospital | |
Taipei, Taiwan |
Principal Investigator: | Susan Shur-Fen Gau, MD, PhD | Dept of Psychiatry, National Taiwan University Hospital |
Responsible Party: | National Taiwan University Hospital ( Susan Shur-Fen Gau ) |
Study ID Numbers: | 200612093M |
Study First Received: | September 13, 2007 |
Last Updated: | August 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00529893 |
Health Authority: | Taiwan: Department of Health |
Attention-deficit/Hyperactivity Disorder neuropsychological functioning Atomoxetine |
Signs and Symptoms Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Atomoxetine |
Neurologic Manifestations Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Dyskinesias |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents |
Adrenergic Uptake Inhibitors Physiological Effects of Drugs Nervous System Diseases Pharmacologic Actions |