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Biomarkers of Treatment Response in ADHD
NCT02623114Phase 4
Key facts
- Status
- Unknown
- Start
- May 2012
- Primary completion
- Aug 2016
- Countries
- 1
- Sponsor
- Seoul National University Children's Hospital
- Modality
- Small Molecules
- Conditions
- attention deficit hyperactivity disorder (ADHD)
01
Overview
Phase 4, open-label trial of methylphenidate and atomoxetine in attention deficit hyperactivity disorder (ADHD) (2 arms), sponsored by Seoul National University Children's Hospital. Primary endpoints: ADHD-Rating Scale at 6 months, Clinical Global Impression - Improvement at 6 months and 1 more. Status: unknown.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Methylphenidate
ADHD patients receiving methylphenidate (Concerta, Metadate, Penid)
Atomoxetine
ADHD patients receiving atomoxetine (Strattera)
03
Who it enrols
Patients aged 6-17 with a confirmed diagnosis of ADHD and IQ > 70. Excludes patients with IQ < 70, hereditary genetic disorders, brain trauma, seizures, or other neurological/psychiatric disorders (ASD, Schizophrenia, MDD, Bipolar, Tourette's, OCD). Also excludes those with a history of methylphenidate treatment lasting more than 1 year or received within the previous 4 weeks.
04
Endpoints
Primary
ADHD-Rating Scale
Clinical Global Impression - Improvement
Continuous Performance Test
Secondary
ADHD-Rating Scale
Side Effect Rating Scale
Clinical Global Impression - Improvement
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