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A double-blind, placebo-controlled study of modified-release methylphenidate in children with
Laurence L Greenhill1, Robert L Findling, James M Swanson
1New York State Psychiatric Institute, New York, New York 10032, USA. larrylgreenhill@cs.com
Insights
Once-daily modified-release methylphenidate (MPH MR) effectively reduced symptoms of attention-deficit/hyperactivity disorder (ADHD) in children. This ADHD treatment was found to be safe and well-tolerated over a 3-week trial.
Area of Science:
- Pediatrics
- Neuroscience
- Psychiatry
Background:
- Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder in children.
- Effective symptom management is crucial for academic and social functioning.
- Modified-release methylphenidate (MPH MR) offers a once-daily dosing option for ADHD treatment.
Purpose of the Study:
- To evaluate the efficacy and safety of once-daily modified-release methylphenidate (MPH MR) compared to placebo.
- To assess the tolerability of MPH MR in pediatric patients diagnosed with ADHD.
Main Methods:
- A 3-week, double-blind, randomized clinical trial involving 321 children (ages 6-16) with ADHD.
- Participants received either MPH MR or placebo, with MPH MR dosage titrated individually up to 60 mg/day.
- Symptom severity was primarily measured using the teacher-rated Conners' Global Index.
Main Results:
- MPH MR significantly reduced ADHD symptom severity across multiple measures, including teacher, parent, and investigator assessments.
- The mean dose of MPH MR reached was 40.7 mg/day.
- Common adverse events included headache, anorexia, abdominal pain, and insomnia, with anorexia being significantly more frequent than in the placebo group.
Conclusions:
- Once-daily MPH MR is an effective and safe treatment for controlling ADHD symptoms throughout the school day.
- The study supports the use of MPH MR as a viable therapeutic option for children with ADHD.
Objective:
To compare the efficacy, safety, and tolerability of once-daily administration of modified-release methylphenidate (MPH MR) with placebo in children with attention-deficit/hyperactivity disorder (ADHD).
Methods:
The study was a 3-week, double-blind, 32-site, randomized clinical trial comparing MPH MR with placebo. Children were 6 to 16 years of age, had a diagnosis of ADHD, and had not failed a previous trial of stimulant treatment for ADHD. After a 1-week, single-blind, placebo-washout period, participants received a once-daily dose of MPH MR or placebo, which was started with 1 capsule (20 mg) and individually titrated up to a maximum of 3 capsules (60 mg). The primary outcome measure was specified as a reduction in ADHD symptom severity from the teacher version of the 10-item Conners' Global Index. Investigators, teachers, and parents evaluated safety.
Results:
The study randomized 321 children: 158 to MPH MR and 163 to placebo. Children in the MPH MR group were started on a dose of 20 mg/d and reached a mean dose of 40.7 mg/d (1.28 mg/kg/d) at endpoint. Compared with placebo, MPH MR significantly reduced ADHD symptoms ratings on the teacher version of the 10-item Conners' Global Index, on the parent version of the Conners' Global Index, on the parent assessment of global efficacy, and on investigator assessment of global improvement. The most common adverse events in the MPH MR group were headache, anorexia, abdominal pain, and insomnia. Only anorexia occurred at a rate that was significantly greater than placebo.
Conclusion:
MPH MR administered once daily in the morning is effective and safe in controlling ADHD symptoms throughout the school day.