An open-label, randomized, active-controlled equivalent trial of osmotic release oral system methylphenidate in...

Area of Science:

• Neuroscience
• Psychiatry
• Pediatrics

Background:

• Attention-deficit/hyperactivity disorder (ADHD) is a prevalent neurodevelopmental disorder in children.
• Methylphenidate (MPH) is a common pharmacotherapy for ADHD, available in various formulations.
• Comparing extended-release and immediate-release MPH formulations is crucial for optimizing treatment.

Purpose of the Study:

• To compare the efficacy and safety of OROS MPH versus IR MPH in Taiwanese children with ADHD.
• To evaluate the impact of different MPH formulations on core ADHD symptoms and social adjustment.
• To assess the rate and profile of side effects between OROS MPH and IR MPH.

Main Methods:

• An open-label, randomized, active-controlled 28-day trial involving 64 children (ages 6-15) diagnosed with DSM-IV ADHD.
• Participants were randomized to receive either OROS MPH once daily or IR MPH three times daily.
• Outcome measures included Conner's Teacher and Parent Rating Scales, social adjustment assessments, and side effect monitoring.

Main Results:

• Both OROS MPH and IR MPH significantly reduced core ADHD symptoms, with no significant difference in the magnitude of reduction between groups.
• The OROS MPH group exhibited a significantly greater rate of symptom reduction and improvement in social adjustment over time.
• No significant differences in the side effect profile were observed between the two treatment groups.

Conclusions:

• OSMPH demonstrates superior efficacy over IR MPH in terms of the magnitude of improvement in ADHD symptoms and social adjustment over the study period.
• OSMPH offers a viable treatment option for pediatric ADHD, providing sustained benefits without an increased risk of side effects in the Chinese population.
• The findings support the use of OROS MPH for improved long-term management of ADHD in children.