Methylphenidate Study in Young Children With Developmental Disorders

PHASE4CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

May 31, 2001

Primary Completion Date

March 31, 2008

Conditions
Attention Deficit Hyperactivity Disorder
Interventions
DRUG

Methylphenidate

"* 1-week single blind placebo lead-in phase.~* step-wise single blind titration of MPH at 1.25 mg bid for the first week, 2.5 mg bid for the second week , 5 mg bid for the third week, 7.5 mg bid for the fourth week and 10 mg bid for the 5th week.~Dose increased if room for improvement in child's symptoms and no clinically important side effects. Dose not increased if no room for improvement in child's symptoms or if clinically important side effects.~After single blind titration, child enters a 4-week double-blind randomized crossover study with placebo and child's best dose that produced maximal effect with minimal side effects, with each child serving as his/her own control."

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

University of Arizona

OTHER

NCT00517504 - Methylphenidate Study in Young Children With Developmental Disorders | Biotech Hunter | Biotech Hunter