Evidence map›Paper›PMID 39394685›Full record

Trial reportJournal of psychopharmacology (Oxford, England)2024

Cognitive effects, pharmacokinetics, and safety of zuranolone administered alone or with alprazolam or ethanol in healthy adults in a phase 1 trial.

Joi Dunbar, David P Walling, Howard A Hassman, Rakesh Jain, Andy Czysz, Indrani Nandy, Victor Ona, Margaret K Moseley, Seth Levin, Paul Maruff

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Journal of psychopharmacology (Oxford, England), 2024. 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. 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

10 authors.

Joi DunbarSage Therapeutics, Inc., Cambridge, MA, USA.ORCID 0009-0004-7663-1535
David P WallingCenExel CNS, Los Alamitos, CA, USA.
Howard A HassmanCenExel Hassman Research Institute, Marlton, NJ, USA.
Rakesh JainTexas Tech University School of Medicine, Austin, TX, USA.
Andy CzyszSage Therapeutics, Inc., Cambridge, MA, USA.
Indrani NandySage Therapeutics, Inc., Cambridge, MA, USA.
Victor OnaSage Therapeutics, Inc., Cambridge, MA, USA.ORCID 0009-0005-7834-6452
Margaret K MoseleyBiogen, Inc., Cambridge, MA, USA.
Seth LevinBiogen, Inc., Cambridge, MA, USA.
Paul MaruffCogstate, New Haven, CT, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundZuranolone is an oral, once-daily, 14-day treatment course approved for adults with postpartum depression in the United States.

aimsTo assess cognitive effects, pharmacokinetics, and safety of zuranolone, alone or with alprazolam/ethanol.

methodsThis was a phase 1, two-part, two-period, randomized, double-blind, placebo-controlled crossover trial. Participants received zuranolone 50 mg or placebo once daily for 9 days, and additionally received alprazolam (1 mg, Part A), ethanol (males: 0.7 g/kg; females: 0.6 g/kg, Part B), or corresponding placebo on days 1, 5, and 9. Within each part, participants received all treatment combinations. Cognition was assessed using a computerized test battery; pharmacokinetics and safety were also evaluated.

resultsAll participants (Part A,

conclusionA general small-to-moderate magnitude decline in cognition occurred with zuranolone alone. Coadministration with alprazolam/ethanol increased the magnitude, but not the duration, of effects compared with single-agent administration. Zuranolone prescribers and patients should be aware of the potential for increased central nervous system-depressant effects if coadministered with GABAergic active compounds such as alprazolam and ethanol.

Indexed as

AlprazolamCognitionCross-Over StudiesEthanolAdolescentAdultDouble-Blind MethodDrug InteractionsFemaleHumansMaleMiddle AgedYoung AdultAlprazolamEthanolCognitive measuresdrug–drug interactionGABAA receptorpostpartum depressionzuranolone

Identifiers

PMID39394685
PMCPMC11531078

What Socratic 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 Socratic graph.