Study designs Laboratory school protocol (LSP)76 Laboratory school protocol (LSP)76
The application of the LSP to the development of stimulant treatments for ADHD is well documented
Uses “cycles of time” to equally expose subjects to different settings in a repeated way across the day
- For ADHD studies, subjects cycle between the analogue classroom and structured activities
- Uses age and developmentally appropriate activities and environmental modifications for preschool and school-aged children
Allows for systematic collection of information deemed to be critical in the standard clinical practice of treating disruptive behavior disorders with medication
- Dosing, safety, attention, behavior, and classroom productivity
Pharmacodynamic (PD) and pharmacokinetic (PK) information can be collected simultaneously
Safety measurements include pulse rate, blood pressure, electrocardiogram, and side effect ratings
The application of the LSP to the development of stimulant treatments for ADHD is well documented
Uses “cycles of time” to equally expose subjects to different settings in a repeated way across the day
– For ADHD studies, subjects
cycle between the analogue
classroom and structured
activities
– Uses age and developmentally
appropriate
activities and environmental
modifications for preschool
and school-aged children
Allows for systematic collection of information deemed to be critical in the standard clinical practice of treating disruptive behavior disorders with medication
– Dosing, safety, attention, behavior, and classroom productivity
Pharmacodynamic (PD) and pharmacokinetic (PK) information can be collected simultaneously
Safety measurements include pulse rate, blood pressure, electrocardiogram, and side effect ratings
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Overview Parallel double-blind placebo controlled CrossoverLaboratory school protocol
Adult workplace environment Pharmacokinetic studies Basic PK measurements