ADHD ADHD,
Conditions
Interventions
Group A MPH administered twice daily (b.i.d.)
Phase 1 : Tritration Phase( Week 0 – 6 ) : Gradual increase to target dose. Participants will get a standard dose up to a child psychitist.
Phase 2
12.00 after meal. and placebo (lactose) at 16.00 P.M. Follow up at week 10.
Phase 3 cross over to three time a day (t.i.d.) ( Week 10 – 14 )
Participants took methylphenidate at 8.00 A.M.,
12.00 after meal and 16.00 P.M. Follow up at week 14.,,Group B MPH administered three time per day (t.i.d.)
Phase 1 : Tritration Phase( Week 0 – 6 ) : Gradual increase to target dose. Participant
12.00 after meal. and 16.00 P.M. Follow up at week 10.
Phase 3 cross over to twice daily (b.i.d.)
Participants took methylphenidate at 8.00 A.M.,
12.00 after meal. and placebo (lactose) at 16.00 P.M. Follow up at week 14.
Active Comparator Drug, ,Active Comparator Drug
Group A MPH administered twice daily (b.i.d.) ,,Group B MPH administered three time per day (t.i.d.)
Sponsors
faculty of medicine siriraj hospital mahidol university, Thailand
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1.New case diagnosis of ADHD by DSM-5 criteria age between 6 years to 17 years 11 months at Child psychiatry department, Siriraj Hospital 2.Patient never used methylphenidate before. 3.Caregiver knowns the patient more than 6 months.
Exclusion criteria
Exclusion criteria: 1. History of methylphenidate allergy. 2. Patient with bipolar disorder, psychotic disorder, autism spectrum disorder, major depressive disorder or intellectual disability 3. The child psychitist prescribed for long acting methylphenidate ex. Concerta 4. Patient who have Heart diease, epilepsy, HT, Tics 5. Patient who got medicine which drug interaction with methylphenidate. 6. Patient who got psychiatric drugs which decrease efficacy of methylphenidate ex. risperidone, clonidine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| symptoms reduction evaluation of Hyperactive, impulsivity and inattentive symptoms by THASS Wk0,6,10,14 Intention-to-treat (ITT) analysis,multiple imputation,t-test ,Chi-square test ,functional impairment evalation by WEISS Functional Impairment Rating Scale Report Wk0,6,10,14 Intention-to-treat (ITT) analysis,multiple imputation,t-test ,Chi-square test | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effect Wk0,6,10,14 Intention-to-treat (ITT) analysis,multiple imputation,t-test ,Chi-square test | — |
Countries
Thailand
Contacts
Public ContactRumrada Kantee
Unaffiliated.
Outcome results
None listed