AI Article Synopsis
- The study aimed to investigate the effects of a new extended-release medication, PRC-063, on sleep in patients with ADHD, comparing it to a placebo in both children (ages 6-12) and adults (18+).
- Researchers had patients maintain daily sleep diaries during two clinical trials after optimizing their dosages, randomizing them to either PRC-063 or placebo for a week.
- Results showed no significant differences in sleep metrics such as total sleep time, efficiency, or latency between those taking PRC-063 and those on placebo, indicating the medication does not affect sleep in ADHD patients.
Article Abstract
Objective: To compare the effect of a once-daily extended-release methylphenidate formulation (PRC-063) versus placebo on sleep, measured via daily electronic diary in two clinical trials in pediatric (6-12 years) and adult (≥18 years) patients with attention deficit hyperactivity disorder (ADHD).
Method: A diary was completed by adult patients or parents/caregivers of pediatric patients during two randomized, double-blind, placebo-controlled laboratory classroom studies. Following dose optimization of PRC-063, patients were randomized to 1 week of double-blind treatment with PRC-063 or placebo before attending a full-day laboratory classroom session.
Results: In the studies, 148 pediatric patients and 239 adult patients were randomized to either PRC-063 or placebo. When compared with the diaries of placebo patients, the sleep diaries in both pediatric and adult patients showed no statistical difference in total sleep time, efficiency, or latency.
Conclusion: PRC-063 did not impact subjective measures of sleep versus placebo in pediatric and adult patients with ADHD.
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Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9606001 | PMC |
| http://dx.doi.org/10.1177/10870547221106238 | DOI Listing |
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