Evidence map›Paper›PMID 39488504›Full record

ArticleSchizophrenia (Heidelberg, Germany)2024

Efficacy of xanomeline and trospium chloride in schizophrenia: pooled results from three 5-week, randomized, double-blind, placebo-controlled, EMERGENT trials.

Inder Kaul, Sharon Sawchak, Amy Claxton, Colin Sauder, Howard H Hassman, Rishi Kakar, David P Walling, Leslie Citrome, Haiyuan Zhu, Andrew C Miller and 1 more

Erratum issued 3 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Schizophrenia (Heidelberg, Germany), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–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.

NCT03697252 phase2completednot on this map

A Phase 2, Randomized, Double-blinded Study to Assess the Safety, Tolerability, and Efficacy of KarXT in Hospitalized Adults With DSM-5 Schizophrenia

TypeinterventionalSponsorKaruna Therapeutics, Inc., a Bristol Myers Squibb companyRan2018 to 2019Enrolled182ConditionsSchizophreniaArmsXanomeline and Trospium Chloride Capsules, Placebo Capsules
NCT04659161 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adults With DSM-5 Schizophrenia

TypeinterventionalSponsorKaruna Therapeutics, Inc., a Bristol Myers Squibb companyRan2020 to 2022Enrolled252ConditionsSchizophrenia, Schizophrenia, PsychosisArmsXanomeline and Trospium Chloride Capsules, Placebo
NCT04738123 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adults With DSM-5 Schizophrenia

TypeinterventionalSponsorKaruna Therapeutics, Inc., a Bristol Myers Squibb companyRan2021 to 2022Enrolled256ConditionsSchizophrenia, Schizophrenia, PsychosisArmsXanomeline and Trospium Chloride Capsules, Placebo
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Article
  6. Review
  7. Review
  8. Article
  9. Xanomeline-Trospium for the Treatment of Schizophrenia.Focus (American Psychiatric Publishing) · 2025
    Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Review
  16. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Inder KaulBristol Myers Squibb, Princeton, NJ, USA.
Sharon SawchakBristol Myers Squibb, Princeton, NJ, USA.
Amy ClaxtonBristol Myers Squibb, Princeton, NJ, USA.
Colin SauderBristol Myers Squibb, Princeton, NJ, USA.
Howard H HassmanCenExel-Hassman Research Institute, Marlton, NJ, USA.
Rishi KakarSegal Trials, Lauderhill, FL, USA.
David P WallingCenExel-Collaborative Neuroscience Research, Los Alamitos, CA, USA.ORCID http://orcid.org/0000-0001-8638-2086
Leslie CitromeNew York Medical College, Valhalla, NY, USA.ORCID http://orcid.org/0000-0002-6098-9266
Haiyuan ZhuBristol Myers Squibb, Princeton, NJ, USA.ORCID http://orcid.org/0009-0007-0903-9349
Andrew C MillerBristol Myers Squibb, Princeton, NJ, USA.
Stephen K BrannanBristol Myers Squibb, Princeton, NJ, USA. sbrannan@karunatx.com.ORCID http://orcid.org/0000-0003-0922-5970

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the 5-week, randomized, double-blind, placebo-controlled EMERGENT-1 (NCT03697252), EMERGENT-2 (NCT04659161), and EMERGENT-3 (NCT04738123) trials, xanomeline and trospium chloride (formerly known as KarXT) significantly improved symptoms of schizophrenia and was generally well tolerated. We pooled data from the EMERGENT trials to further characterize the efficacy of xanomeline/trospium and provide sufficient statistical power to analyze responses in participant subgroups. In pooled analyses, xanomeline/trospium significantly improved Positive and Negative Syndrome Scale (PANSS) total score at week 5 versus placebo (least squares mean difference, -9.9; 95% confidence interval, -12.4, -7.3; p < 0.0001; Cohen's d effect size, 0.65). PANSS subscale and Clinical Global Impression-Severity scores also improved significantly with xanomeline/trospium versus placebo. Subgroup analyses consistently favored xanomeline/trospium over placebo regardless of differences in participant age, sex, race, body mass index, and baseline PANSS total score. These results add to existing evidence demonstrating robust and reliable improvements in symptoms with xanomeline/trospium across a broad spectrum of people with schizophrenia.

Identifiers

PMID39488504
PMCPMC11531488

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.