Attention Deficit Disorder With HyperactivityNCT00529893
Efficacy of Atomoxetine in the Neuropsychological Tests Among Children With ADHD
An observational study of Attention Deficit Disorder With Hyperactivity, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2007to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Subjects are diagnosed as DSM-IV, Attention Deficit Hyperactivity Disorder (ADHD).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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:
- 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).
- 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.
- 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.
- Keywords
- Attention-deficit/Hyperactivity Disorder, neuropsychological functioning, Atomoxetine
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
The Efficacy of Once-Daily Atomoxetine Hydrochloride on Executive Function in Taiwanese Children with Attention-deficit/ Hyperactivity Disorder
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startJul 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Susan Shur-Fen Gau, MD, PhD, Principal investigator, Dept of Psychiatry, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529893
- Sponsor's protocol ID
- 200612093M
- Status last verified
- Oct 2013
- First submitted
- 13 Sep 2007
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1017/S1461145709990836. Epub 2009 Oct 23.
PubMed 19849892
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Atomoxetine in the Neuropsychological Tests Among Children With ADHD
- ClinicalTrials.gov ID
- NCT00529893
- Acronym / sponsor ID
- 200612093M
- Keywords
- Attention-deficit/Hyperactivity Disorder, neuropsychological functioning, Atomoxetine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Jul 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 14 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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:
- 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).
- 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.
- 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 design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subjects are diagnosed as DSM-IV, Attention Deficit Hyperactivity Disorder (ADHD).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Derived from this study: PubMed 19849892Gau 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. doi: 10.1017/S1461145709990836. Epub 2009 Oct 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Shur-Fen Gau, MD, PhD principal investigator
Dept of Psychiatry, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Disorder With Hyperactivity, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Efficacy of Once-Daily Atomoxetine Hydrochloride on Executive Function in Taiwanese Children with Attention-deficit/ Hyperactivity Disorder (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00529893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.