International Study to Predict Optimised Treatment in Children and Adolescents with Attention Deficit/Hyperactivity Disorder
Phase 4
Recruiting
- Conditions
- Attention Deficit/Hyperactivity Disorder (ADHD) in children and adolescentsMental Health - Other mental health disorders
- Registration Number
- ACTRN12609000271202
- Lead Sponsor
- Brain Resource Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1344
Inclusion Criteria
Meet Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria for primary diagnosis of ADHD, have an Attention Deficit / Hyperactivity Disorder Rating Scale (ADHD-RS IV) score > 6 for inattention and/or hyperactivity-impulsivity, subject is a candidate for methylphenidate, and is stimulant naive or stimulant free. Fluent and literate in English or Dutch.
Exclusion Criteria
Prior or recent use of methylphenidate of other stimulant medication. History of brain injury/blow resulting in loss of consciousness. Severe impediment to vision, hearing and/or hand movement which may interfere with their ability to complete the protocol required tests.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite markers from 165 different assessments/variables will be assessed to identify genetic, brain structure/function and cognitive markers (or combination of markers) which predict acute drug treatment response in ADHD. This will be assessed using: The MINI International Neuropsychatric Interview for Children and Adolescents, ADHD Rating Scale IV, Conners Rating Scales - Revised (Long versions - parent and teacher). Web based questionnaire (web-Q), including: Brain Resource Inventory of Social Cognition (BRISC), Depression, Anxiety and Stress Scale (DASS21), Neuroticism, Extraversion, and Openness Five Factor Inventory (NEO-FFI), Paediatric Quality of Life Inventory (PEDS-QL). Psychophysiological assessment (including, respiratory rate, sweat rate, Electroencephalography (EEG) and Event Related Potential) and a Cognitive test battery. Genetic analysis. Structural and functional magnetic resonance imaging (MRI).[6 weeks after baseline visit.]
- Secondary Outcome Measures
Name Time Method To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months. Using Conners Rating Scales - Revised (Long versions - parent and teacher) and Paediatric Quality of Life Inventory (PEDS-QL).[Week 52]