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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00917371 |
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Date of registration:
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08/06/2009 |
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Primary sponsor: |
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Public title:
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The Effectiveness of Atomoxetine on Brain Imaging, Neuropsychological, and Social Functions in Adults With Attention Deficit/Hyperactivity Disorder
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Scientific title:
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The Effectiveness of Atomoxetine on Brain Imaging, Neuropsychological, and Social Functions in Adults With Attention Deficit/Hyperactivity Disorder |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00917371 |
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Study type:
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Observational |
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Study design:
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N/A
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Susan Shur-Fen Gau, MD, PhD |
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Address:
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Telephone:
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+886-2-23123456 |
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Email:
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gaushufe@ntu.edu.tw |
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Affiliation:
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Name:
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Susan Shur-Fen Gau, MD, PhD |
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Address:
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Telephone:
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+886-2-23123456 |
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Email:
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gaushufe@ntu.edu.tw |
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Affiliation:
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Name:
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Susan Shur-Fen Gau, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Taiwan University Hospital & College of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- The inclusion criteria are (1) that subjects had typical ADHD symptoms before 7 years
old which meet the DSM-IV-TR ADHD at childhood and currently based on Gau's clinic
diagnosis and the ADHD supplement of the K-SADS for adults; (2) that their Clinical
Global Impressions-ADHD-Severity (CGI-ADHD-S) score>4 and psychotropic
medication-naïve for the past year; (3) that their IQ greater than 80; and (4) that
they consent to this study and they can keep appointments for clinic visits and all
tests.
Exclusion Criteria:
These subjects will be excluded from the study if they have any of the following criteria:
- (1) Comorbid with DSM-IV-TR diagnosis of pervasive developmental disorder,
schizophrenia, schizoaffective disorder, delusional disorder, other psychotic
disorder, organic psychosis, schizotypal personality disorder, bipolar affective
disorder, and mental retardation; (2) In the major depressive episode, comorbid with
severe anxiety disorders or during substance intoxication or withdrawal at the time
of evaluation; (3) With neurodegenerative disorder, epilepsy, involuntary movement
disorder, congenital metabolic disorder, brain tumor, history of severe head trauma,
and history of craniotomy; (4) A history of alcohol or drug abuse within the past 3
months; (5) The need of psychotropic medications apart from MPH or atomoxetine,
including Chinese medicine or health-food supplements that have central nervous
system activity; and (6) With visual or hearing impairments, or motor disability
which may influence the process of neuropsychological assessment. Subjects will be
discontinued from this study in the following circumstances: pregnancy,
non-compliance with study drug, an adverse event, subject's request of withdrawal,
and loss of follow-up.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Attention Deficit Hyperactivity Disorder
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Secondary ID(s)
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200903059M
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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