The effects of Concerta® on the brain structures of children with attention deficit hyperactivity disorder, measured by optimised Voxel-Based Morphometry (VBM) and Tract-Based Spatial Statistics (TBSS) of Diffusion Tensor Imaging (DTI).

ISRCTN	ISRCTN44227400
DOI	https://doi.org/10.1186/ISRCTN44227400
Protocol serial number	2005-0161
Sponsor	Janssen Korea Ltd (South Korea)
Funders	Janssen Korea Ltd (South Korea), Asan Medical Centre (South Korea), National Research Foundation of Korea (South Korea)

Submission date: 14/04/2008
Registration date: 22/04/2008
Last edited: 10/12/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Hanik Yoo
Scientific

388-1 Pungnap-2 dong
Songpa-gu
Seoul
138-736
Korea, South

Study information

Primary study design	Interventional
Study design	Prospective open-label controlled study
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	COSA
Study objectives	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(s)	Ethics approval received from the Institutional Review Board (IRB) of the Asan Medical Centre (AMC) on the 22nd August 2005.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Methyphenidate (Concerta®)
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Years
Upper age limit	12 Years
Sex	Male
Target sample size at registration	80
Key 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)
Key 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)
Date of first enrolment	23/08/2005
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Korea, South

Study participating centre

388-1 Pungnap-2 dong

Seoul
138-736
Korea, South

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes