Condition category
Mental and Behavioural Disorders
Date applied
14/04/2008
Date assigned
22/04/2008
Last edited
10/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hanik Yoo

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Janssen Korea Ltd (South Korea)

Sponsor details

12th Floor Sungwon Building
141 Samsung-Dong
Gangnam-ku
Seoul
135-090
Korea
South

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes