Trial reportClinical pharmacology and therapeutics2021
Benefit-Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment-Resistant Depression.
Trial report in Clinical pharmacology and therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled 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.
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.
Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- The use of esketamine in the treatment of patients with oral antidepressant-resistant depression: systematic review and meta-analysis.Revista da Associacao Medica Brasileira (1992) · 2023Pooled it
- The use of esketamine in the treatment of patients with severe depression and suicidal ideation: systematic review and meta-analysis.Revista da Associacao Medica Brasileira (1992) · 2023Pooled it
- Efficacy of Analgesic Propofol/Esketamine and Propofol/Fentanyl for Painless Induced Abortion: A Randomized Clinical Trial.BioMed research international · 2022Trial
- Population-based estimates of different dosage types of psychedelic use across socio-demographic groups in Germany.Scientific reports · 2025Article
- Antidepressants and Weight Gain: An Update on the Evidence and Clinical Implications.Current obesity reports · 2025Review
- Research trends in esketamine for depression over the past decade: a bibliometric analysis.Frontiers in psychiatry · 2025Review
- Cognitive Safety is Largely Ignored in Clinical Drug Trials: A Study of Registered Study Protocols.Drug safety · 2024Article
- The efficacy of nasal administration of esketamine in patients having moderate-to-severe pain after preoperative CT-guided needle localization: a randomized, double-blind, placebo-controlled trial.Frontiers in medicine · 2024Article
- Esketamine Nasal Spray: Rapid Relief for TRD and Suicide Prevention-Mechanisms and Pharmacodynamics.Neuropsychiatric disease and treatment · 2024Review
- Comments to Drs Taillefer de Laportalière, Jullien, Yrondi, Cestac, and Montastruc.Psychological medicine · 2023Article
- Overcoming the myths of esketamine administration: different and not difficult.Frontiers in psychiatry · 2023Review
- The role of serotonin neurotransmission in rapid antidepressant actions.Psychopharmacology · 2022Review
- U.S. Food and Drug Administration's Patient-Focused Drug Development Initiative: Experience with Integration of Patient-Experience Data in a New Drug Application for Esketamine Nasal Spray Plus a Newly Initiated Oral Antidepressant for Treatment-Resistant Depression.Therapeutic innovation & regulatory science · 2022Article
- Clinical Guidelines of the Egyptian Psychiatric Association for the Management of Treatment-Resistant Unipolar Depression in Egypt.Frontiers in psychiatry · 2022Article
- Review
- The mediating role of social support in the relationship between nurses' psychological capital and depression during public health emergencies in tertiary medical institutions.American journal of translational research · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This post hoc analysis assessed the benefit-risk profile of esketamine nasal spray + oral antidepressant (AD) induction and maintenance treatment in patients with treatment-resistant depression (TRD). The Benefit-Risk Action Team framework was utilized to assess the benefit-risk profile using data from three induction studies and one maintenance study. Benefits were proportion of remitters or responders in induction studies and proportion of stable remitters or stable responders who remained relapse-free in the maintenance study. Risks were death, suicidal ideation, most common adverse events (AEs), and potential long-term risks. Per 100 patients on esketamine + AD vs. AD + placebo in induction therapy, 5-21 additional patients would remit and 14-17 additional patients would respond. In maintenance therapy, 19-32 fewer relapses would occur with esketamine. In both cases, there was little difference in serious or severe common AEs (primarily dissociation, vertigo, and dizziness). These findings support a positive benefit-risk balance for esketamine + AD as induction and maintenance treatment in patients with TRD.
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What OpenQuestion holds
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.