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

UMIN ID: UMIN000001542

Registered date:02/12/2008

Basic Information

• Health condition(s) or Problem(s) studied: Attention-deficit/hyperactivity disorder
• Date of first enrollment: 2009/01/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 8-week methylphenidate administration

Outcome(s)

• Primary Outcome: Relation between hemodynamic changes detected by near-infrared spectroscopy and difference of AD/HD symptoms.
• Secondary Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: 6years-old
• Age maximum: 12years-old
• Gender: Male and Female
• Exclude 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).

Related Information

• Primary Sponsor: Shimada Ryoiku Center
• Secondary Sponsor: 1.National Center of Neurology and Psychiatry 2.Rissho University
• Source(s) of Monetary Support: None