Quetiapine and Concerta in the Treatment for ADHD and Aggressive Behavior.

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

February 29, 2004

Primary Completion Date

November 30, 2005

Study Completion Date

November 30, 2005

Conditions
Attention Deficit Disorder With Hyperactivity
Interventions
DRUG

Oros Methylphenidate

"Oros methylphenidate will be titrated over 3 visits according to the following schedule:~* Visit 2 dose of 18 mg QAM~* Visit 3 dose of 36mg QAM~* Visit 4 dose of 54mg QAM."

DRUG

quetiapine

"Quetiapine will be titrated according to the following schedule as determined by efficacy and safety assessments (See Table 1).~Table 1: Quetiapine Dosing Schedule (subject's required weight = 30-80 kg)~* Visit 5 dose of 25mg BID~* Visit 6 dose of 50mg BID~* Visit 7 dose of 100mg BID~* Visit 8 dose of 200mg BID~* Visit 9 dose of 300mg BID~Efficacy: For any visit following Visit 5, dosage will remain stable if clinically significant improvement criteria are met.If subjects subsequently fail to meet clinically significant improvement criteria, dose increases will resume at the next level of the dosing schedule."

Trial Locations (1)

46202

Riley Childrens Hospital, Indianapolis

All Listed Sponsors
lead

Indiana University School of Medicine

OTHER

NCT00550147 - Quetiapine and Concerta in the Treatment for ADHD and Aggressive Behavior. | Biotech Hunter | Biotech Hunter