Evidence map›Paper›PMID 28568608›Full record

Trial reportHuman psychopharmacology2017

Next-day residual effects of flibanserin on simulated driving performance in premenopausal women.

Gary G Kay, Thomas Hochadel, Eric Sicard, Karthi K Natarajan, Noel N Kim

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Human psychopharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.6field-weighted citation impact, top 19% 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

14 citing papers in PubMed, 26 citations in OpenAlex.

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  11. Pharmacotherapy for Sexual Dysfunction in Women.Current psychiatry reports · 2022
    Review
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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 2 institutions in 1 country.

Gary G KayCognitive Research Corp., Saint Petersburg, Florida, USA.
Thomas HochadelCognitive Research Corp., Saint Petersburg, Florida, USA.
Eric SicardAlgorithme Pharma, Montreal, Quebec, Canada.
Karthi K NatarajanSprout Pharmaceuticals, Raleigh, North Carolina, USA.
Noel N KimInstitute for Sexual Medicine, San Diego, California, USA.ORCID 0000-0003-1843-5363
Cognitive Research (United States) · USCloud Pharmaceuticals (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe objective of this study was to determine the next-day residual effects of acute and steady-state nighttime dosing of flibanserin on simulated driving performance and cognitive function in healthy premenopausal women.

methodsIn this randomized, double-blind, placebo-controlled, four-way crossover study, 72 subjects were treated with either acute oral doses of placebo, zopiclone 7.5 mg (positive control) or flibanserin 100 mg at bedtime (indicated therapeutic dose), or after chronic nightly oral doses of flibanserin 100 mg for 1 week followed by a single bedtime dose of flibanserin 200 mg (supratherapeutic dose). Simulated driving assessments were conducted 9 hr after dosing and cognitive function tests were administered immediately before or during the driving assessment.

resultsZopiclone increased standard deviation of lateral position (≥3.1 cm; p < .0001) relative to placebo and impaired other parameters previously shown to be sensitive to sedation. No impairment was detected for flibanserin at either dose relative to placebo. Flibanserin 200 mg was similar to the 100-mg dose on cognitive testing and driving performance even though commonly reported adverse events for flibanserin were predictably increased at the higher dose.

conclusionsAt both therapeutic and supratherapeutic doses, flibanserin did not impair next-day driving performance and cognitive function compared to placebo.

Indexed as

Automobile DrivingAdministration, OralAdultAzabicyclo CompoundsBenzimidazolesCognitionContraceptives, Oral, HormonalCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansHypnotics and SedativesPiperazinesPremenopauseReaction TimeAzabicyclo CompoundsBenzimidazolesContraceptives, Oral, HormonalflibanserinHypnotics and SedativesPiperazineszopicloneAddyihypoactive sexual desire disordermultifunctional serotonin agonist and antagonist

Identifiers

PMID28568608
PMCPMC5697607
OpenAlexW2620544918

What OpenQuestion holds

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LicenceCC BY-NC
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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.