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).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN44227400

Enrollment

Registered

2008-04-22

Start date

2005-08-23

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention deficit hyperactivity disorder (ADHD) Mental and Behavioural Disorders Hyperkinetic disorders

Interventions

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

Eligibility

Sex/Gender

Male

Inclusion criteria

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)

Exclusion criteria

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)

Design outcomes

Secondary

Measure	Time frame
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	—

Primary

Measure	Time frame
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.	—

Countries

Korea, South

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026