Evidence map›Paper›PMID 39360294›Full record

ArticleAlpha psychiatry2024

The Resistant Depression Response to Esketamine Assessing Metabolomics (ReDREAM) Project-Untargeted Metabolomics to Identify Biomarkers of Treatment Response to Intranasal Esketamine in Individuals with Treatment-Resistant Depression: A Study Protocol.

Francesco Bartoli, Daniele Cavaleri, Ilaria Riboldi, Cristina Crocamo, Renato de Filippis, Riccardo Zandonella Callegher, Giuseppe Paglia, Umberto Albert, Pasquale De Fazio, Giuseppe Carrà

Abstract read
In one paragraph

Article in Alpha psychiatry, 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. 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

10 authors.

Francesco BartoliSchool of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.ORCID 0000-0003-2612-4119
Daniele CavaleriSchool of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.ORCID 0000-0001-5342-9394
Ilaria RiboldiSchool of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.ORCID 0000-0002-8188-800X
Cristina CrocamoSchool of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.ORCID 0000-0002-2979-2107
Renato de FilippisDepartment of Health Sciences, University "Magna Graecia" of Catanzaro, Catanzaro, Italy.ORCID 0000-0001-6928-1224
Riccardo Zandonella CallegherDepartment of Medicine, Surgery and Health Sciences, University of Trieste, Trieste, Italy.ORCID 0009-0003-5193-6909
Giuseppe PagliaSchool of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.ORCID 0000-0003-4724-6801
Umberto AlbertDepartment of Medicine, Surgery and Health Sciences, University of Trieste, Trieste, Italy.ORCID 0000-0001-9781-4219
Pasquale De FazioDepartment of Health Sciences, University "Magna Graecia" of Catanzaro, Catanzaro, Italy.ORCID 0000-0001-5375-3565
Giuseppe CarràSchool of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.ORCID 0000-0001-5375-3565

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: Treatment-resistant depression (TRD) affects around 20-30% of people with major depressive disorder. In 2019, esketamine nasal spray was approved for TRD by both the US Food and Drug Administration and the European Medicines Agency. While its clinical efficacy and safety are proven, the mechanisms underlying its antidepressant effect remain unclear. The use of metabolomics may allow understanding the metabolic effects of esketamine and predicting biological features associated with clinical response in TRD. Nonetheless, there is a lack of studies exploring the predictive value of metabolomics. The Resistant Depression Response to Esketamine Assessing Metabolomics (ReDREAM) project aims at identifying metabolic biosignatures that may represent novel correlates of response to esketamine treatment. Study Design: This is the protocol of an observational, prospective study. Methods: We plan to select 60 people with TRD from 3 clinical sites in Italy. The participants will be administered with esketamine nasal spray, following standard clinical practice, twice a week for 4 weeks ("induction phase"), then once a week for 4 additional weeks ("maintenance phase"). We will test the correlations between baseline metabolic profile and depressive symptom improvement at study endpoints (weeks 4 and 8) and we will explore the likelihood of different metabolic phenotypes between responders and non-responders. Expected results: An involvement of energy metabolism, amino acid metabolism, urea cycle, and nitric oxide synthesis in response to treatment with esketamine nasal spray is hypothesized. Conclusion: Unbiased data from untargeted metabolomics associated with clinical changes after esketamine treatment may contribute to define new paradigms for precision psychiatry-oriented, personalized care of TRD.

Indexed as

Biomarkersesketaminemajor depressive disordermetabolomics

Identifiers

PMID39360294
PMCPMC11443282

What OpenQuestion 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 OpenQuestion graph.