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An exploratory study for development of hemodynamic indicators for clinical effectiveness of methylphenidate in children with AD/HD

An exploratory study for development of hemodynamic indicators for clinical effectiveness of methylphenidate in children with AD/HD - An exploratory study for development of hemodynamic indicators for clinical effectiveness of methylphenidate in children with AD/HD

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001542
Enrollment
20
Registered
2008-12-02
Start date
2009-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention-deficit/hyperactivity disorder

Interventions

8-week methylphenidate administration

Sponsors

Shimada Ryoiku Center
Lead Sponsor
1.National Center of Neurology and Psychiatry 2.Rissho University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. A patient who is more than 6-yaer old and under 12-year old when informed consent was obtained from their parents or guardians. 2. A patient who is diagnosed to have AD/HD by child psychiatrists or child neurologists based on DSM-IV-TR. 3. A patient whose parents or guradians can give written informed consent.

Exclusion criteria

Exclusion criteria: 1. A patient with severe anxiety or agitation. 2. A patient with glaucoma. 3. A patient with thyroidal dysfunction 4. A patient with arrythmia or abnormal blood pressure. 5. A patient with history of allergic reaction or severe side effects with methylphenidate. 6. A patient with severe mood disorder 7. A patient with motor tics, Tourette's syndrome, or family history of Tourette's syndrome. 8. A patient with pheochromocytoma. 9. A patient who receives medication of MAO inhibitor. 10. A patient with epilepsy. 11. A patient with schizophrenia, psychotic disorders, bipolar disorder. 12. A patient with history of drug abuse or alcohol dependence. 13. A patient with significant mental retardation (FIQ<70, WISC-III).

Design outcomes

Primary

MeasureTime frame
Relation between hemodynamic changes detected by near-infrared spectroscopy and difference of AD/HD symptoms.

Secondary

MeasureTime frame
1) Assessment of behavioral disturbances(CBCL) 2) Assessment of general function(GAF) 3) Assessment of comorbidities(SCAS,CDRS,PARS) 4) Assessment of self-estimate(JSSC)

Countries

Japan

Contacts

Public ContactHiroshi Ozawa

Shimada Ryoiku Center Department of Pediatrics

h.ozawa@shimada-ryoiku.or.jp042-374-2071

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026