Identification of Neuropsychological, Genetic and Neuroimaging Markers and Treatment Response Predictors of ADHD

• Conditions: Attention Deficit Disorder With Hyperactivity
• Interventions: Drug: Methylphenidate (MPH); Drug: Atomoxetine

• Registration Number: NCT02430896
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-04-27
• Study First Posted: 2015-04-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05
• Primary Completion: 2020-06-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ADHD group	Methylphenidate (MPH)	Children and adolescents who met the Diagnostic and Statistical Manual IV Text Revision (DSM-IV-TR) diagnostic criteria for ADHD and needed pharmacotherapy. Subjects will be taking Methylphenidate or Atomoxetine for 52 weeks.
ADHD group	Atomoxetine	Children and adolescents who met the Diagnostic and Statistical Manual IV Text Revision (DSM-IV-TR) diagnostic criteria for ADHD and needed pharmacotherapy. Subjects will be taking Methylphenidate or Atomoxetine for 52 weeks.

Primary Outcome Measures

Name	Time	Method
Wide genome analysis regarding genetic polymorphisms as predictors of treatment response in Attention-Deficit/Hyperactivity Disorder(ADHD).	visit 1 (-week 8)	Genome wide case-control association analysis will be operated with qualified phenotype and assigned intermittent phenotype.
Neuroimaging analysis as predictors of treatment response in Attention-Deficit/Hyperactivity Disorder(ADHD).	visit 1 (-week 8)	Thickness of cortex, anatomical relation will be compared with 3 tesla MRI. In addition, brain circuit for delayed aversion, delayed frustration, time processing and resting state.
Drug effectiveness is assessed using ADHD rating scale, CGI -S (Clinical Global Impression - Severity scale) and CGI-I (Clinical Global Impression - Improvement scale).	visit 1 (-week 8)
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	visit 1 (-week 8)	Using a complex neuropsychological test consisting of The stop-signal reaction time (SSRT) task, delayed aversion, delayed frustration, time processing, Advanced tets of Attention (ATA).
Comorbidity assessment using a composite measure consisting of K-PRC, C-SSRS, TCGI, and DCDQ	visit1 (-week 8)	It is assessed using a composite measure consisting of Korean Personality Rating Scale for Children (K-PRC), Columbia Suicide Severity Rating Scale (C-SSRS), The Tic Severity Scale (TCGI), and The Developmental Coordination Disorder Questionnaire (DCDQ).

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of