Evidence map›Paper›PMID 35786058›Full record

Trial reportJournal of attention disorders2022

Analysis of Daily Sleep Diary Measures From Multilayer Extended-Release Methylphenidate (PRC-063) Studies in Children and Adults With ADHD.

Marc Cataldo, Graeme Donnelly, Andrew J Cutler, Ann Childress, Jaromir Mikl, Sailaja Bhaskar, James Waxmonsky

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of attention disorders, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.5field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 2 countries.

Marc CataldoPurdue Pharma L.P., Stamford, CT, USA.ORCID 0000-0003-1918-8130
Graeme DonnellyPurdue Pharma (Canada), Pickering, ON, Canada.ORCID 0000-0002-7664-6436
Andrew J CutlerSUNY Upstate Medical University, Lakewood Ranch, FL, USA.
Ann ChildressCenter for Psychiatry and Behavioral Medicine, Inc., Las Vegas, NV, USA.ORCID 0000-0001-5782-7891
Jaromir MiklPurdue Pharma L.P., Stamford, CT, USA.ORCID 0000-0002-5658-9809
Sailaja BhaskarImbrium Therapeutics L.P., a subsidiary of Purdue Pharma L.P., Stamford, CT, USA.ORCID 0000-0003-2495-4602
James WaxmonskyPenn State College of Medicine, Hershey, PA, USA.ORCID 0000-0002-5563-3417
Purdue Pharma (United States) · USCenter for Psychiatry and Behavioral Medicine · USPenn State Milton S. Hershey Medical Center · USPurdue Pharma (Canada) · CASUNY Upstate Medical University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo 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).

methodA 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.

resultsIn 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.

conclusionPRC-063 did not impact subjective measures of sleep versus placebo in pediatric and adult patients with ADHD.

Indexed as

Attention Deficit Disorder with HyperactivityCentral Nervous System StimulantsMethylphenidateAdultChildDelayed-Action PreparationsDose-Response Relationship, DrugDouble-Blind MethodHumansSleepTreatment OutcomeCentral Nervous System StimulantsDelayed-Action PreparationsMethylphenidateadult ADHDelectronic diaryextended-release stimulantmethylphenidatesleep

Identifiers

PMID35786058
PMCPMC9606001
OpenAlexW4283781071

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.