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 |
| Secondary identifying numbers | 2005-0161 |
- 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
Scientific
388-1 Pungnap-2 dong
Songpa-gu
Seoul
138-736
Korea, South
Study information
| Study design | Prospective open-label controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 23/08/2005 |
| 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 number of participants | 80 subjects (ADHD 50 subjects; control 30 subjects) (added 10/12/09) |
| 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
138-736
Korea, South
Sponsor information
Janssen Korea Ltd (South Korea)
Industry
Industry
12th Floor Sungwon Building
141 Samsung-Dong
Gangnam-ku
Seoul
135-090
Korea, South
"ROR" |
https://ror.org/04yzcpd71 |
|---|
Funders
Funder type
Hospital/treatment centre
Janssen Korea Ltd (South Korea)
No information available
Asan Medical Centre (South Korea)
No information available
National Research Foundation of Korea (South Korea)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- 한국연구재단이 창의적 연구와, National Research Foundation (South Korea), NRF
- Location
- Korea, South
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
