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

NCT02430896 | Unknown

• 1 other identifier: S2013-0373-0014
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Neuropsychological; neuroimaging; genetic markers; treatment response predictor

Outcome Measures

Primary Outcomes (5)

• Wide genome analysis regarding genetic polymorphisms as predictors of treatment response in Attention-Deficit/Hyperactivity Disorder(ADHD).

  Genome wide case-control association analysis will be operated with qualified phenotype and assigned intermittent phenotype.

  visit 1 (-week 8)

• Neuroimaging analysis as predictors of treatment response in Attention-Deficit/Hyperactivity Disorder(ADHD).

  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.

  visit 1 (-week 8)

• 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

  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).

  visit 1 (-week 8)

• Comorbidity assessment using a composite measure consisting of K-PRC, C-SSRS, TCGI, and DCDQ

  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).

  visit1 (-week 8)

Other Outcomes (8)

• Change from baseline in treatment response effectiveness of pharmacotherapy at week12

  visit 3 (week12)

• Change from baseline in treatment response effectiveness of pharmacotherapy at week 24

  visit 4 (week 24)

• Change from baseline in treatment response effectiveness of pharmacotherapy at week 36

  visit 5 (week 36)

Study Arms (2)

ADHD group

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.

Drug: Methylphenidate (MPH); Drug: Atomoxetine

Normal control group

Children and adolescents will be recruited by advertisement, and will be assigned to normal group if they do not meet the Diagnostic and Statistical Manual IV Text Revision (DSM-IV-TR) diagnostic criteria for ADHD .

Interventions

Methylphenidate (MPH) DRUG

Subjects of ADHD group will be taking methylphenidate or atomoxetine for 52 weeks.

Also known as: Metadate CD®, Concerta®, Medikinet Retard®

ADHD group

Atomoxetine DRUG

Subjects of ADHD group will be taking methylphenidate or atomoxetine for 52 weeks.

Also known as: Straterra®

ADHD group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• presence of intellectual disability or learning disorder
• past and/or current history of bipolar disorder or psychosis or substance use disorder
• past and/or current history of pervasive developmental disorder, organic mental disorder or other neurological disorder
• presence of sever suicidal ideation
• presence of tic disorder or obsessive-compulsive disorder whose symptoms needed pharmacotherapy
• presence of family history with Tourette's Syndrome
• took medication with methylphenidate or atomoxetine with last 6 month (or more than 3 month)
• presence of severe medical condition (ex. cardiologic, liver, kidney, pulmonary, glaucoma)
• took alpha 2 adrenergic receptor agonist, antidepressant, antipsychotics, benzodiazepine, modafinil, antiepileptic drug or dietary supplement that have a influence on Central Nervous System (CNS).
• presence of possibility with pregnancy
• especially for neuroimaging,
• uncooperative with claustrophobia or body movement
• metal material inside body that can't take off

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood sample for GWAS (Genome-Wide Association Study)

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate; Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propylamines; Amines

Study Officials

• Hyo-Won Kim, Professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

myungeun lee, BA

CONTACT

+82-2-3010-7190; lme23@amc.seoul.kr

Sojung Park, BA

CONTACT

+82-2-3010-7190; sojung@amc.seoul.kr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, department of psychiatry, Asan Medical Center

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 30, 2015
• Study Start: February 1, 2015
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)