Evidence map›Paper›PMID 34880615›Full record

ArticleNeuropsychiatric disease and treatment2021

Effect of Sleep Disturbance on Efficacy of Esketamine in Treatment-Resistant Depression: Findings from Randomized Controlled Trials.

Stephane Borentain, David Williamson, Ibrahim Turkoz, Vanina Popova, William V McCall, Maju Mathews, Frank Wiegand

Open access · goldAbstract read
In one paragraph

Article in Neuropsychiatric disease and treatment, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 12% of its field
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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. The Association between Intranasal Esketamine and Treatment-emergent Insomnia in the Treatment of Treatment-resistant Major Depression: A Meta-analysis.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2025
    Article
  3. Article
  4. Observational
  5. Review
  6. Review
  7. 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

7 authors at 3 institutions in 2 countries.

Stephane BorentainDepartment of Global Medical Affairs, Janssen Research & Development, LLC, Titusville, NJ, USA.ORCID 0000-0003-3312-1557
David WilliamsonCNS Scientific Affairs Liaisons, Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
Ibrahim TurkozDepartment of Clinical Statistics, Janssen Research & Development, LLC, Titusville, NJ, USA.ORCID 0000-0003-1891-2297
Vanina PopovaDepartment of Neuroscience Clinical Development, Janssen Research & Development, Beerse, Belgium.
William V McCallDepartment of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA, USA.
Maju MathewsDepartment of Global Medical Affairs, Janssen Research & Development, LLC, Titusville, NJ, USA.
Frank WiegandDepartment of Global Medical Affairs, Janssen Research & Development, LLC, Titusville, NJ, USA.
Janssen (United States) · USAugusta University · USJanssen (Belgium) · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the relationship of sleep disturbance to the antidepressant effects of esketamine. MATERIALS AND

methodsTwo double-blind, 4-week studies randomized adults with treatment-resistant depression (TRD) to placebo or esketamine nasal spray, each with newly initiated antidepressant. Sleep was assessed using Montgomery-Åsberg Depression Rating Scale (MADRS) item 4. Change in response (≥50% decrease in MADRS total score) and remission (total MADRS score ≤12) at day 28 was examined by presence/absence of baseline sleep disturbance using logistic regression models. Impact on reported sleep disturbance (MADRS item 4 score) was examined using ANCOVA models.

resultsAt baseline, most patients reported disturbed sleep - moderate/severe (65.3%, 369/565), mild (25.3%, 143/565), or none/slightly (9.4%, 53/565) - with similar distribution between treatment groups. A higher proportion of esketamine-treated patients achieved response (OR = 2.05; 95% CI: 1.40-3.02;

conclusionAntidepressant efficacy of esketamine was demonstrated in patients with TRD, regardless of the presence of sleep disturbance. After 8 days of treatment and thereafter, significantly more esketamine-treated patients reported improvement in sleep versus antidepressant plus placebo.

Indexed as

esketamineinsomniasleep disturbancetreatment-resistant depression

Identifiers

PMID34880615
PMCPMC8646953
OpenAlexW3216474897

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.