At a glance
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An Open-Label Study of Quetiapine Added to Oros Methylphenidate in the Treatment of ADHD and Aggressive Behavior
In Brief
A Phase 2 clinical trial evaluating Oros Methylphenidate and quetiapine for Attention Deficit Disorder With Hyperactivity. Completed, enrolled 30 participants across 1 site.
Detailed Summary
The primary purpose of this thirteen-week, open-label study is to test the hypothesis that quetiapine in combination with Oros methylphenidate will reduce aggressive symptoms in children and adolescents who have shown inadequate response to OROS methylphenidate alone.
Study Details
Timeline
Interventions
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.
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.