drugset / Trial / NCT00550147

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

NCT00550147 ↗

Phase 2 Completed 30 enrolled Indiana University
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2004-02
Primary completion
2005-11
Completion
2005-11

Outcome

Met primary endpoint

registry p <0.05; Mean Difference (Final Values) -1.125 (95% CI -1.52 to -0.72); t-test, 2 sided NCT00550147 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylphenidate Small molecule 54 mg —
Subject Quetiapine Small molecule 25 mg —
Subject Quetiapine Small molecule 50 mg —
Subject Quetiapine Small molecule 100 mg —
Subject Quetiapine Small molecule 200 mg —
Subject Quetiapine Small molecule 300 mg —