Evidence map›Paper›PMID 39302437›Full record

Trial reportPsychopharmacology2025

Effects of zuranolone on next-day simulated driving in healthy adults.

Joi Dunbar, Gaetano Morelli, Rakesh Jain, Carrie Vaudreuil, Indrani Nandy, Victor Ona, Margaret K Moseley, Seth Levin, Gary Kay

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Psychopharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Review
  2. Review
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

9 authors.

Joi DunbarSage Therapeutics, Inc., Cambridge, MA, USA. joi.dunbar@sagerx.com.
Gaetano MorelliAlta Sciences, Montréal, QC, Canada.
Rakesh JainTexas Tech University School of Medicine - Permian Basin, Midland, TX, USA.
Carrie VaudreuilSage Therapeutics, Inc., Cambridge, MA, USA.
Indrani NandySage Therapeutics, Inc., Cambridge, MA, USA.
Victor OnaSage Therapeutics, Inc., Cambridge, MA, USA.
Margaret K MoseleyBiogen Inc., Cambridge, MA, USA.
Seth LevinBiogen Inc., Cambridge, MA, USA.
Gary KayCognitive Research Corporation, St. Petersburg, FL, USA.

Funding

Biogen BiogenSage Therapeutics Sage Therapeutics
6 · The paper itself

Abstract

rationaleZuranolone is an oral positive allosteric modulator of GABA

objectiveEvaluate the effect of zuranolone on simulated driving performance.

methodsIn this randomized, double-blind, active- and placebo-controlled, four-period crossover study, treatments included once-nightly zuranolone 50 mg on days 1-7, zuranolone 50 mg on days 1-6 and zuranolone 100 mg on day 7, zopiclone 7.5 mg on days 1 and 7, and placebo on days 1-7. Driving was assessed using a validated simulator. Primary endpoint was standard deviation of lateral position (SDLP), evaluated 9 h post-dose on days 2 and 8. Secondary endpoints included additional driving assessments, cognitive tests, pharmacokinetics, and safety.

resultsHealthy adults (N = 67) enrolled and received ≥ 1 dose. Zuranolone 50 mg increased SDLP versus placebo on days 2 (least squares mean difference [LSMD]: 7.4 cm; p < 0.0001) and 8 (LSMD: 4.6 cm; p = 0.0106). Zuranolone 100 mg evoked a larger increase in SDLP versus placebo on day 8 (LSMD 18.9 cm; p < 0.0001). Reduced performance in other driving assessments and cognition were observed with zuranolone 50 mg on day 2; many resolved by day 8. Despite the SDLP observations, most participants judged themselves capable of driving. Frequent adverse events (≥ 20%) were CNS-related; most were mild/moderate.

conclusionZuranolone impaired simulated driving and reduced cognitive function versus placebo 9 h after administration. Although many impairments resolved after 7 days of dosing, driving remained impaired. These results may inform prescriber decision-making.

Indexed as

Automobile DrivingAdultAzabicyclo CompoundsCognitionCross-Over StudiesDouble-Blind MethodFemaleHealthy VolunteersHumansMaleMiddle AgedPiperazinesPsychomotor PerformanceYoung AdultAzabicyclo CompoundsPiperazineszopicloneGABAA receptor modulatorNeuroactive steroidNext-day driving effectsPostpartum depressionSimulated drivingZuranolone

Identifiers

PMID39302437
PMCPMC11775036

What OpenQuestion holds

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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.