Evidence map›Paper›PMID 21256805›Full record

Trial reportSleep medicine2011

Pimavanserin tartrate, a 5-HT(2A) receptor inverse agonist, increases slow wave sleep as measured by polysomnography in healthy adult volunteers.

Sonia Ancoli-Israel, Kimberly E Vanover, David M Weiner, Robert E Davis, Daniel P van Kammen

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Sleep medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 15% 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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 54 citations in OpenAlex.

  1. New Antipsychotic Medications in the Last Decade.Current psychiatry reports · 2021
    Pooled it
  2. Review
  3. Review
  4. Article
  5. Article
  6. Review
  7. "Selective" serotonin 5-HTBiochemical pharmacology · 2022
    Review
  8. Pimavanserin, a 5HTJournal of neurochemistry · 2021
    Article
  9. Review
  10. The 5-HTThe Journal of pharmacology and experimental therapeutics · 2019
    Article
  11. Pimavanserin use in a movement disorders clinic: a single-center experience.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2018
    Article
  12. Novel Bivalent 5-HTACS chemical neuroscience · 2018
    Article
  13. Article
  14. Treatment of Sleep Dysfunction in Parkinson's Disease.Current treatment options in neurology · 2017
    Review
  15. Article
  16. Review
  17. Review
  18. 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

5 authors at 5 institutions in 2 countries.

Sonia Ancoli-IsraelDepartment of Psychiatry, University of California San Diego, La Jolla, CA 92093-0733, USA. sancoliisrael@ucsd.edu
Kimberly E Vanover
David M Weiner
Robert E Davis
Daniel P van Kammen
CHDI Foundation · USIntra Cellular Therapies (United States) · USMerck Serono (Italy) · ITPharmaceutical Product Development (United States) · USUniversity of California, San Diego · US

Funding

SLEEP CONSOLIDATION IN A NURSING HOME POPULATIONR01AG008415 · NIA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI ANCOLI-ISRAEL, SONIA · 1989 to 2011
$3.0M
NIA NIH HHS R01 AG008415
6 · The paper itself

Abstract

objectiveDetermine the effects of pimavanserin tartrate [ACP-103; N-(4-flurophenylmethyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phenylmethyl)carbamide], a selective serotonin 5-HT(2A) receptor inverse agonist, on slow wave sleep (SWS), other sleep parameters, and attention/vigilance.

methodsForty-five healthy adults were randomized to pimavanserin (1, 2.5, 5, or 20 mg) or placebo in a double-blind fashion (n=9/group). Pimavanserin or placebo was administered once daily in the morning for 13 consecutive days. The effects of pimavanserin were measured after the first dose and again after 13 days. Sleep parameters were measured by polysomnography. Effects on attention/vigilance were measured by a continuous performance task.

resultsCompared to placebo, pimavanserin significantly increased SWS following single and multiple dose administration. Pimavanserin also decreased number of awakenings. PSG variables not affected by pimavanserin included sleep period time, total sleep time, sleep onset latency, number of stage shifts, total time awake, early morning wake, and microarousal index. Changes in sleep architecture parameters, sleep profile parameters, and spectral power density parameters were consistent with a selective increase in SWS. Pimavanserin did not adversely affect performance on the continuous performance test measured in the evening before or morning after polysomnography.

conclusionsThese data suggest that pimavanserin selectively increases slow wave sleep and decreases awakenings, an effect that does not diminish with repeated administration.

Indexed as

PolysomnographyAdultAgedDouble-Blind MethodFemaleHuman ExperimentationHumansMaleMiddle AgedPatient CompliancePiperidinesPlacebo EffectSerotonin 5-HT2 Receptor AntagonistsSleepUreapimavanserinPiperidinesSerotonin 5-HT2 Receptor AntagonistsUrea

Identifiers

PMID21256805
PMCPMC3137254
OpenAlexW2134583432

What OpenQuestion holds

Textmetadata
LicenceTDM
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.