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

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ClinicalTrials.gov Identifier: NCT02430896
Recruitment Status : Recruiting
First Posted : April 30, 2015
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Hyo-Won Kim, 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.

Condition or disease Intervention/treatment
Attention Deficit Disorder With Hyperactivity Drug: Methylphenidate (MPH) Drug: Atomoxetine

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Neuropsychological, Genetic and Neuroimaging Markers and Treatment Response Predictors of Attention-Deficit/Hyperactivity Disorder (ADHD)
Study Start Date : February 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2020


Group/Cohort Intervention/treatment
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)
Subjects of ADHD group will be taking methylphenidate or atomoxetine for 52 weeks.
Other Names:
  • Metadate CD®
  • Concerta®
  • Medikinet Retard®

Drug: Atomoxetine
Subjects of ADHD group will be taking methylphenidate or atomoxetine for 52 weeks.
Other Name: Straterra®

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 .



Primary Outcome Measures :
  1. Wide genome analysis regarding genetic polymorphisms as predictors of treatment response in Attention-Deficit/Hyperactivity Disorder(ADHD). [ Time Frame: visit 1 (-week 8) ]
    Genome wide case-control association analysis will be operated with qualified phenotype and assigned intermittent phenotype.

  2. Neuroimaging analysis as predictors of treatment response in Attention-Deficit/Hyperactivity Disorder(ADHD). [ Time Frame: 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.

  3. Drug effectiveness is assessed using ADHD rating scale, CGI -S (Clinical Global Impression - Severity scale) and CGI-I (Clinical Global Impression - Improvement scale). [ Time Frame: visit 1 (-week 8) ]
  4. 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 [ Time Frame: 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).

  5. Comorbidity assessment using a composite measure consisting of K-PRC, C-SSRS, TCGI, and DCDQ [ Time Frame: 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).


Other Outcome Measures:
  1. Change from baseline in treatment response effectiveness of pharmacotherapy at week12 [ Time Frame: visit 3 (week12) ]
    Drug effectiveness is assessed using ADHD rating scale, CGI -S (Clinical Global Impression - Severity scale) and CGI-I (Clinical Global Impression - Improvement scale).

  2. Change from baseline in treatment response effectiveness of pharmacotherapy at week 24 [ Time Frame: visit 4 (week 24) ]
    Drug effectiveness is assessed using ADHD rating scale, CGI -S (Clinical Global Impression - Severity scale) and CGI-I (Clinical Global Impression - Improvement scale).

  3. Change from baseline in treatment response effectiveness of pharmacotherapy at week 36 [ Time Frame: visit 5 (week 36) ]
    Drug effectiveness is assessed using ADHD rating scale, CGI -S (Clinical Global Impression - Severity scale) and CGI-I (Clinical Global Impression - Improvement scale).

  4. Change from baseline in treatment response effectiveness of pharmacotherapy at week 52 [ Time Frame: visit 6 (week 52) ]
    Drug effectiveness is assessed using ADHD rating scale, CGI -S (Clinical Global Impression - Severity scale) and CGI-I (Clinical Global Impression - Improvement scale).

  5. 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 [ Time Frame: visit 3 (week 12) ]
    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).

  6. 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 [ Time Frame: visit 6 (week 52) ]
    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).

  7. Occurrence of comorbidity from baseline in assessment using a composite measure consisting of K-PRC, C-SSRS, TCGI, and DCDQ at week 12 [ Time Frame: visit 3 (week 12) ]
    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).

  8. Occurrence of comorbidity from baseline in assessment using a composite measure consisting of K-PRC, C-SSRS, TCGI, and DCDQ at week 52 [ Time Frame: visit 6 (week 52) ]
    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).


Biospecimen Retention:   Samples With DNA
whole blood sample for GWAS (Genome-Wide Association Study)


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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02430896


Contacts
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Contact: myungeun lee, BA +82-2-3010-7190 lme23@amc.seoul.kr
Contact: Sojung Park, BA +82-2-3010-7190 sojung@amc.seoul.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Hyo-Won Kim, MD, PhD    82-3010-3414    shingubi@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Hyo-Won Kim, Professor Asan Medical Center

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Responsible Party: Hyo-Won Kim, Assistant professor, department of psychiatry, Asan Medical Center, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02430896     History of Changes
Other Study ID Numbers: S2013-0373-0014
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hyo-Won Kim, Asan Medical Center:
Neuropsychological
neuroimaging
genetic markers
treatment response predictor

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Atomoxetine Hydrochloride
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents