Evidence map›Paper›PMID 21681607›Full record

Trial reportPharmaceutical research2011

Modeling sleep data for a new drug in development using markov mixed-effects models.

Maria C Kjellsson, Daniele Ouellet, Brian Corrigan, Mats O Karlsson

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Pharmaceutical research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.3field-weighted citation impact, top 12% 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

10 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Pharmacodynamic models for discrete data.Clinical pharmacokinetics · 2012
    Review
  7. Article
  8. Article
  9. Article
  10. Relationship between zolpidem concentrations and sleep parameters in pediatric burn patients.Journal of burn care & research : official publication of the American Burn Association
    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

4 authors at 2 institutions in 2 countries.

Maria C KjellssonDepartment of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden. maria.kjellsson@farmbio.uu.se
Daniele Ouellet
Brian Corrigan
Mats O Karlsson
Pfizer (United States) · USUppsala University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo characterize the time-course of sleep in insomnia patients as well as placebo and concentration-effect relationships of two hypnotic compounds, PD 0200390 and zolpidem, using an accelerated model-building strategy based on mixed-effects Markov models.

methodsData were obtained in a phase II study with the drugs. Sleep stages were recorded during eight hours of sleep for two nights per treatment for the five treatments. First-order Markov models were developed for one transition at a time in a sequential manner; first a baseline model, followed by placebo and lastly the drug models. To accelerate the process, predefined models were selected based on a priori knowledge of sleep, including inter-subject and inter-occasion variability.

resultsBaseline sleep was described using piece-wise linear models, depending on time of night and duration of sleep stage. Placebo affected light sleep stages; drugs also affected slow-wave sleep. Administering PD 0200390 30 min earlier than standard dosing was shown through simulations to reduce latency to persistent sleep by 40%.

conclusionThe proposed accelerated model-building strategy resulted in a model well describing sleep patterns of insomnia patients with and without treatments.

Indexed as

Markov ChainsAcetatesAdultCross-Over StudiesCyclopentanesDouble-Blind MethodFemaleHumansHypnotics and SedativesLinear ModelsMaleMiddle AgedPolysomnographyPyridinesSleepSleep Initiation and Maintenance Disorders(1-aminomethyl-3,4-dimethylcyclopentyl)acetic acidAcetatesCyclopentanesHypnotics and SedativesPyridinesZolpidem

Identifiers

PMID21681607
OpenAlexW2061725368

What OpenQuestion holds

Textmetadata
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.