Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2005-0161
Study information
Scientific title
Acronym
COSA
Study hypothesis
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
Please note that as of 02/09/09 the the imaging techniques used in this trial have been updated. The original techniques which were to be used are three-dimensional magnetic resonance (3D-MR) volumetry and diffusion-tensor imaging (DTI). The trial name and primary outcome field have been updated accordingly. Please also note that the target of 30 participants was expanded due to a high dropout rate during follow up and the anticipated end date has been changed from 31/12/2008 to 31/12/2012.
Please note that as of 10/12/09 the target number of participants has been changed from 120 to 80.
Ethics approval
Ethics approval received from the Institutional Review Board (IRB) of the Asan Medical Centre (AMC) on the 22nd August 2005.
Study design
Prospective open-label controlled study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Attention deficit hyperactivity disorder (ADHD)
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Methyphenidate (Concerta®)
Primary outcome measure
Current information as of 02/09/09:
Image analysis data including cortical thickness, shape analysis, and diffusion tensor image, measured at baseline, 2 months, 1 years, 2 years and 3 years
Initial information at time of registration:
Cortical thickness changes measured by 3D-MR, measured at baseline, eight weeks, and one year.
Secondary outcome measures
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
Overall trial start date
23/08/2005
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
5. Healthy control group (age-matched boys) (added 02/09/09)
Participant type
Patient
Age group
Child
Gender
Male
Target number of participants
80 subjects (ADHD 50 subjects; control 30 subjects) (added 10/12/09)
Participant exclusion criteria
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)
Recruitment start date
23/08/2005
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Korea, South
Trial participating centre
388-1 Pungnap-2 dong
Seoul
138-736
Korea, South
Funders
Funder type
Hospital/treatment centre
Funder name
Janssen Korea Ltd (South Korea)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Asan Medical Centre (South Korea)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Research Foundation of Korea (South Korea)
Alternative name(s)
NRF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Korea, South
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list