Efficacy of Atomoxetine in the Neuropsychological Tests Among Children With ADHD

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: NCT00529893
Recruitment Status : Unknown
Verified October 2013 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 14, 2007
Last Update Posted : October 21, 2013
Eli Lilly and Company
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
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 or disease
Attention Deficit Disorder With Hyperactivity

Detailed Description:

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:

  1. To 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).
  2. To examine the efficacy of atomoxetine on other neuropsychological measures including the Wisconsin Card Sorting Test (WCST), and the attention, memory, and paired learning tests of the CANTAB.
  3. To validate the ADHD using psychopathological, neuropsychological, functional brain imaging, behavioral, and social correlates.

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 : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Official Title: Efficacy of Atomoxetine in the Neuropsychological Tests Among Children With ADHD
Study Start Date : July 2007
Actual Primary Completion Date : April 2013

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The Efficacy of Once-Daily Atomoxetine Hydrochloride on Executive Function in Taiwanese Children with Attention-deficit/ Hyperactivity Disorder [ Time Frame: 12 weeks ]
    Patients with ADHD performed worse in the backward digit span task, CPT, IED and RVIP than the controls. Their significant improvement in executive function after treatment with atomoxetine for 4 weeks included fewer omission and commission errors, fewer hit reaction time standard errors, and less variability in the CPT; fewer total errors and trials in the IED; higher probability of hits, total correction rejection, and total hits, fewer total misses, and shorter latency in the RVIP; longer span length and fewer total usage errors in the SSP; fewer errors and strategy utilization in the SWM; and more problems solved, fewer mean moves, and shorter subsequent thinking time in the SOC. Atomoxetine significantly reduced ADHD-related symptoms over time.

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Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.

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): NCT00529893

National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Eli Lilly and Company
Principal Investigator: Susan Shur-Fen Gau, MD, PhD Dept of Psychiatry, National Taiwan University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: National Taiwan University Hospital Identifier: NCT00529893     History of Changes
Other Study ID Numbers: 200612093M
First Posted: September 14, 2007    Key Record Dates
Last Update Posted: October 21, 2013
Last Verified: October 2013

Keywords provided by National Taiwan University Hospital:
Attention-deficit/Hyperactivity Disorder
neuropsychological functioning

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs