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ISRCTN
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ISRCTN44227400
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ClinicalTrials.gov identifier
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Public title
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The effects of Concerta® on the brain structures of children with attention deficit hyperactivity disorder, measured by three-dimensional magnetic resonance (3D-MR) volumetry and diffusion-tensor imaging (DTI)
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Scientific title
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Acronym
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COSA
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Serial number at source
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2005-0161
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Study hypothesis
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1. Methyphenidate (Concerta®) will change the brain structures of subjects with attention-deficit hyperactivity disorder (ADHD)
2. Structural changes of brain will be correlated with the changes of symptoms severity after treatment
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Ethics approval
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Ethics approval received from the Institutional Review Board (IRB) of the Asan Medical Center (AMC) on the 22nd August 2005.
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Study design
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Prospective, open-label, controlled study
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Countries of recruitment
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South Korea
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Disease/condition/study domain
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Attention deficit hyperactivity disorder (ADHD)
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Participants - inclusion criteria
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1. Aged 6 - 12 years old, male only
2. ADHD diagnosed by the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (KSADS-PL)
3. Right-handedness
4. ADHD rating scale score greater than 24
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Participants - exclusion criteria
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1. Intelligence quotient (IQ) less than or equal to 70 measured by the Wechsler Intelligence Scale for Children - Revised (WISC-R)
2. Neurological diseases such as cerebral palsy, seizure disorder, head trauma etc.
3. Autistic spectrum disorder
4. History or current diagnosis of tic disorder, schizophrenia, bipolar disorder, major depression, anxiety disorder and other psychosis
5. History of psychotropic medication usage
6. Contra-indication of magnetic resonance imaging (MRI) scanning (e.g., pacemaker insertion)
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Anticipated start date
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23/08/2005
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Anticipated end date
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31/12/2008
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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30
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Interventions
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Day 0: Concerta® 18 mg
Week 2: Concerta® 36 mg
Week 4: Concerta® 54 mg
Dosage can be adjusted according to clinical symptoms and adverse effects. Patients will be treated for one year, and a patient follow-up will be performed for one year.
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Primary outcome measure(s)
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Cortical thickness changes measured by 3D-MR, measured at baseline, eight weeks, and one year.
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Secondary outcome measure(s)
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1. ADHD rating scale by investigator, measured at baseline, eight weeks, and one year
2. Clinical Global Impression - Improvement/Severity (CGI-I/S) scale, measured at every visit
3. Junior Temperament and Character Inventory, measured at baseline, eight weeks, and one year
4. Computerised neurocognitive function tests, measured at baseline, eight weeks, and one year
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Sources of funding
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1. Janssen Korea Ltd (South Korea)
2. Asan Medical Center (South Korea)
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Trial website
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Publications
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Contact name
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Dr
Hanik
Yoo
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Address
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388-1 Pungnap-2 dong
Songpa-gu
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City/town
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Seoul
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Zip/Postcode
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138-736
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Country
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Korea, South
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Sponsor
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Janssen Korea Ltd (South Korea)
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Address
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12th Floor Sungwon Building
141 Samsung-Dong
Gangnam-ku
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City/town
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Seoul
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Zip/Postcode
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135-090
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Country
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Korea, South
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Date applied
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14/04/2008
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Last edited
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22/04/2008
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Date ISRCTN assigned
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22/04/2008
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