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

Asan Medical Center

Status: Unknown

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Drug: Atomoxetine; Drug: Methylphenidate (MPH)

Study type: Observational

Funder types: Other

Identifiers

NCT02430896

S2013-0373-0014

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

600 participants in 2 patient groups

ADHD group

Description:

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.

Treatment:

Drug: Methylphenidate (MPH)

Drug: Atomoxetine

Normal control group

Description:

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 .