Clinical trial NCT02430896: Identification of Neuropsychological, Genetic and Neuroimaging Markers and Treatment Response Predictors of ADHD
Official title: Neuropsychological, Genetic and Neuroimaging Markers and Treatment Response Predictors of Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Neuropsychological
neuroimaging
genetic markers
treatment response predictor
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 600
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Total 600 children and adolescents will be enrolled in this study. 500 patients in psychiatric outpatient will be enrolled. 100 persons of healthy volunteers will be recruited via advertisements.

Brief summary: The objective of this study is to identification of neuropsychological, genetic and neuroimaging markers and treatment response predictors of attention-deficit/hyperactivity disorder (ADHD). Participants who take the standardized pharmacotherapy (methylphenidate or atomoxetine) for ADHD will be observed for 52 weeks. They will do several neuropsychological, neuroimaging and genetic tests at visit 1\~6.


Eligibility criteria: Inclusion Criteria:

1. aged between 6 and 12 years
2. met the Diagnostic and Statistical Manual IV Text Revision (DSM-IV-TR) diagnostic criteria for ADHD and needed pharmacotherapy.
3. Informed consent

Exclusion Criteria:

1. presence of intellectual disability or learning disorder
2. past and/or current history of bipolar disorder or psychosis or substance use disorder
3. past and/or current history of pervasive developmental disorder, organic mental disorder or other neurological disorder
4. presence of sever suicidal ideation
5. presence of tic disorder or obsessive-compulsive disorder whose symptoms needed pharmacotherapy
6. presence of family history with Tourette's Syndrome
7. took medication with methylphenidate or atomoxetine with last 6 month (or more than 3 month)
8. presence of severe medical condition (ex. cardiologic, liver, kidney, pulmonary, glaucoma)
9. took alpha 2 adrenergic receptor agonist, antidepressant, antipsychotics, benzodiazepine, modafinil, antiepileptic drug or dietary supplement that have a influence on Central Nervous System (CNS).
10. presence of possibility with pregnancy
11. especially for neuroimaging,

    1. uncooperative with claustrophobia or body movement
    2. metal material inside body that can't take off

Primary outcomes:
measure: Wide genome analysis regarding genetic polymorphisms as predictors of treatment response in Attention-Deficit/Hyperactivity Disorder(ADHD).
timeFrame: visit 1 (-week 8)
measure: Neuroimaging analysis as predictors of treatment response in Attention-Deficit/Hyperactivity Disorder(ADHD).
timeFrame: visit 1 (-week 8)
measure: Drug effectiveness is assessed using ADHD rating scale, CGI -S (Clinical Global Impression - Severity scale) and CGI-I (Clinical Global Impression - Improvement scale).
timeFrame: visit 1 (-week 8)
measure: Neuropsychological markers as the treatment response predictable factor of ADHD using a complex neuropsychological test consisting of SSRT, delayed aversion, delayed frustration, time processing, ATA
timeFrame: visit 1 (-week 8)
measure: Comorbidity assessment using a composite measure consisting of K-PRC, C-SSRS, TCGI, and DCDQ
timeFrame: visit1 (-week 8)
Secondary outcomes:
Other outcomes:
measure: Change from baseline in treatment response effectiveness of pharmacotherapy at week12
timeFrame: visit 3 (week12)
measure: Change from baseline in treatment response effectiveness of pharmacotherapy at week 24
timeFrame: visit 4 (week 24)
measure: Change from baseline in treatment response effectiveness of pharmacotherapy at week 36
timeFrame: visit 5 (week 36)
measure: Change from baseline in treatment response effectiveness of pharmacotherapy at week 52
timeFrame: visit 6 (week 52)
measure: Change from baseline in neuropsychological markers as the treatment response predictable factor of ADHD using a complex neuropsychological test consisting of SSRT, delayed aversion, delayed frustration, time processing, ATA at week 12
timeFrame: visit 3 (week 12)
measure: Change from baseline in neuropsychological markers as the treatment response predictable factor of ADHD using a complex neuropsychological test consisting of SSRT, delayed aversion, delayed frustration, time processing, ATA at week 52
timeFrame: visit 6 (week 52)
measure: Occurrence of comorbidity from baseline in assessment using a composite measure consisting of K-PRC, C-SSRS, TCGI, and DCDQ at week 12
timeFrame: visit 3 (week 12)
measure: Occurrence of comorbidity from baseline in assessment using a composite measure consisting of K-PRC, C-SSRS, TCGI, and DCDQ at week 52
timeFrame: visit 6 (week 52)
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Hyo-Won Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References: