Evidence map›Paper›PMID 26707087›Full record

Trial reportBiological psychiatry2016

Intravenous Esketamine in Adult Treatment-Resistant Depression: A Double-Blind, Double-Randomization, Placebo-Controlled Study.

Jaskaran B Singh, Maggie Fedgchin, Ella Daly, Liwen Xi, Caroline Melman, Geert De Bruecker, Andre Tadic, Pascal Sienaert, Frank Wiegand, Husseini Manji and 2 more

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Biological psychiatry, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 222 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
222citing papers in PubMed, 19 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.

NCT04414943 nacompletednot on this mapstarted 2020, after this paper: background citation

Effects of Low-dose S-ketamine on the Incidence of Postpartum Depression in Women With Prenatal Depression: a Randomized, Double-blind, Placebo-controlled Trial

TypeinterventionalSponsorPeking University First HospitalRan2020 to 2022Enrolled364ConditionsPrenatal Depression, Ketamine, Postpartum DepressionArmsS-ketamine, Placebo
NCT05229913 phase4unknown statusnot on this mapstarted 2022, after this paper: background citation

Effects of Different Concentrations of Esketamine on Postpartum Depression After Cesarean Section

TypeinterventionalSponsorQinghai UniversityRan2022 to 2023Enrolled500ConditionsPostpartum DepressionArmsEsketamine is not added, Esketamine 0.2mg/kg, Esketamine 0.4mg/kg, Esketamine 0.6mg/kg, Esketamine 0.8mg/kg
3 · Its place in the literature

Who cites it

222 citing papers in PubMed, 19 syntheses or guidelines pooled it.

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162 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Jaskaran B SinghJanssen Research & Development, LLC, San Diego, California. Electronic address: jsingh25@its.jnj.com.
Maggie FedgchinJanssen Research & Development, LLC, San Diego, California.
Ella DalyJanssen Research & Development, LLC, San Diego, California.
Liwen XiJanssen Research & Development, LLC, San Diego, California.
Caroline MelmanJanssen-Cilag B.V., Tilburg, Netherlands.
Geert De BrueckerPsychiatric Hospital Zoete Nood Gods, Lede, Belgium.
Andre TadicDepartment of Psychiatry and Psychotherapy, University Medical Centre, Mainz, Germany.
Pascal SienaertDepartment of Mood Disorders, University Psychiatric Centre, Katholieke Universiteit Leuven (University of Leuven), Leuven.
Frank WiegandJanssen Research & Development, LLC, San Diego, California.
Husseini ManjiJanssen Research & Development, LLC, San Diego, California.
Wayne C DrevetsJanssen Research & Development, LLC, San Diego, California.
Luc Van NuetenJanssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe purpose of this study was to assess the efficacy and safety and to explore the dose response of esketamine intravenous (IV) infusion in patients with treatment-resistant depression (TRD).

methodsThis multicenter, randomized, placebo-controlled trial was conducted in 30 patients with TRD. Patients were randomly assigned 1:1:1 to receive an IV infusion of .20 mg/kg or .40 mg/kg esketamine or placebo over 40 minutes on day 1. The primary end point was change in Montgomery-Åsberg Depression Rating Scale total score from day 1 (baseline) to day 2. Nonresponders who received placebo on day 1 were randomly assigned again 1:1 to IV esketamine .20 mg/kg or .40 mg/kg on day 4. Secondary efficacy and safety measures were also evaluated.

resultsOf the enrolled patients, 97% (29 of 30) completed the study. The least squares mean changes (SE) from baseline to day 2 in Montgomery-Åsberg Depression Rating Scale total score for the esketamine .20 mg/kg and .40 mg/kg dose groups were -16.8 (3.00) and -16.9 (2.61), respectively, and showed significant improvement (one-sided p = .001 for both groups) compared with placebo (-3.8 [2.97]). Esketamine showed a rapid (within 2 hours) and robust antidepressant effect. Treatment-emergent adverse events were dose dependent. The most common treatment-emergent adverse events were headache, nausea, and dissociation; the last-mentioned was transient and did not persist beyond 4 hours from the start of the esketamine infusion.

conclusionsA rapid onset of robust antidepressant effects was observed in patients with TRD after a 40-minute IV infusion of either .20 mg/kg or .40 mg/kg of esketamine. The lower dose may allow for better tolerability while maintaining efficacy.

Indexed as

AdolescentAdultDepressive Disorder, Treatment-ResistantDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansInfusions, IntravenousKetamineMaleMiddle AgedYoung AdultKetamineEfficacyEsketamineIntravenousSafetyTRDTreatment-resistant depression

Identifiers

PMID26707087

What OpenQuestion holds

Textmetadata
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.