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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Neuropsychological, Genetic and Neuroimaging Markers and Treatment Response Predictors of Attention-Deficit/Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02430896
• Other study ID #: S2013-0373-0014
• Status: Recruiting
• Start date: February 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2019
• Source: Asan Medical Center
• Contact: myungeun lee, BA
• Phone: +82-2-3010-7190
• Email: lme23[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Drug:
• Methylphenidate (MPH)
Subjects of ADHD group will be taking methylphenidate or atomoxetine for 52 weeks.
• Atomoxetine
Subjects of ADHD group will be taking methylphenidate or atomoxetine for 52 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in treatment response effectiveness of pharmacotherapy at week12	Drug effectiveness is assessed using ADHD rating scale, CGI -S (Clinical Global Impression - Severity scale) and CGI-I (Clinical Global Impression - Improvement scale).	visit 3 (week12)
Other	Change from baseline in treatment response effectiveness of pharmacotherapy at 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).	visit 4 (week 24)
Other	Change from baseline in treatment response effectiveness of pharmacotherapy at 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).	visit 5 (week 36)
Other	Change from baseline in treatment response effectiveness of pharmacotherapy at 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).	visit 6 (week 52)
Other	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	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 3 (week 12)
Other	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	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 6 (week 52)
Other	Occurrence of comorbidity from baseline in assessment using a composite measure consisting of K-PRC, C-SSRS, TCGI, and DCDQ at 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).	visit 3 (week 12)
Other	Occurrence of comorbidity from baseline in assessment using a composite measure consisting of K-PRC, C-SSRS, TCGI, and DCDQ at 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).	visit 6 (week 52)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)