CONCERTA Lab School Study
Summary
The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.
Timeline
- Start
- 2009-01-02
- Primary completion
- 2009-06-26
- Completion
- 2009-06-26
Outcome
Met primary endpoint
registry MEAN Placebo: 88.0 (Standard Deviation 39.79) Problems attempted MEAN Concerta: 116.1 (Standard Deviation 38.99) Problems attempted NCT00799487 ↗
registry analysis (unspecified test); Placebo vs Concerta; p <0.0001; LS Mean Difference -27.3 (95% CI -34.4 to -20.2) NCT00799487 ↗
registry MEAN Placebo: 84.0 (Standard Deviation 39.93) Problems correct MEAN Concerta: 112.8 (Standard Deviation 39.60) Problems correct NCT00799487 ↗
registry analysis (unspecified test); Placebo vs Concerta; p <0.0001; LS Mean Difference -28.0 (95% CI -35.1 to -20.8) NCT00799487 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylphenidate | Small molecule | 18 mg | Oral |
| Subject | Methylphenidate | Small molecule | 54 mg | Oral |