Evidence map›Paper›PMID 35078950›Full record

ArticleClinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology2022

Long-term Safety and Efficacy of Esketamine Nasal Spray Plus an Oral Antidepressant in Patients with Treatment-resistant Depression- an Asian Sub-group Analysis from the SUSTAIN-2 Study.

Hong Jin Jeon, Po-Chung Ju, Ahmad Hatim Sulaiman, Salina Abdul Aziz, Jong-Woo Paik, Wilson Tan, Daisy Bai, Cheng-Ta Li

Abstract read
In one paragraph

Article in Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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

16 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Korean Medication Algorithm for Depressive Disorder 2025, Fifth Revision: An Executive Summary.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2025
    Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. The Dropout Rates and Associated Factors in Patients with Mood Disorders in Long-term Naturalistic Treatment.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2024
    Article
  11. Antidepressants enter cells, organelles, and membranes.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2024
    Review
  12. Review
  13. Article
  14. Ketamine and the neurobiology of depression: Toward next-generation rapid-acting antidepressant treatments.Proceedings of the National Academy of Sciences of the United States of America · 2023
    Review
  15. Article
  16. 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

8 authors.

Hong Jin JeonDepartment of Psychiatry, Depression Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-6126-542X
Po-Chung JuInstitute of Medicine, Chung Shan Medical University, Taichung, Taiwan.ORCID https://orcid.org/0000-0002-6708-4339
Ahmad Hatim SulaimanDepartment of Psychological Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.ORCID https://orcid.org/0000-0002-8364-4594
Salina Abdul AzizDepartment of Psychiatry and Mental Health, Hospital Kuala Lumpur, Kuala Lumpur, Malaysia.ORCID https://orcid.org/0000-0002-4967-9224
Jong-Woo PaikDepartment of Psychiatry, Kyung Hee University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-1804-8497
Wilson TanRegional Medical Affairs, Janssen Pharmaceutical Companies of Johnson and Johnson, Singapore.ORCID https://orcid.org/0000-0003-4832-156X
Daisy BaiStatistics & Decision Sciences, Janssen Research & Development, LLC, Shanghai, China.ORCID https://orcid.org/0000-0003-2641-4714
Cheng-Ta LiDivision of Community & Rehabilitation Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan.ORCID https://orcid.org/0000-0002-0670-1153

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the long-term safety and efficacy of intranasal esketamine in patients with treatment-resistant depression from the Asian subgroup of the SUSTAIN-2 study.

methodsSUSTAIN-2 was a phase 3, open-label, single-arm, multicenter study comprising a 4-week screening, 4-week induction, 48-week optimization/maintenance, and 4-week follow-up (upon esketamine discontinuation) phase. Patients with treatment-resistant depression received esketamine plus an oral antidepressant during the treatment period.

resultsThe incidence of ≥ 1 serious treatment-emergent adverse event (TEAE) among the 78 subjects from the Asian subgroup (Taiwan: 33, Korea: 26, Malaysia: 19) was 11.5% (n = 9); with no fatal TEAE. 13 Asian patients (16.7%) discontinued esketamine due to TEAEs. The most common TEAEs were dizziness (37.2%), nausea (29.5%), dissociation (28.2%), and headache (21.8%). Most TEAEs were mild to moderate in severity, transient and resolved on the same day. Upon discontinuation of esketamine, no trend in withdrawal symptoms was observed to associate long-term use of esketamine with withdrawal syndrome. There were no reports of drug seeking, abuse, or overdose. Improvements in symptoms, functioning and quality of life, occurred during in the induction phase and were generally maintained through the optimization/maintenance phases of the study.

conclusionThe safety and efficacy of esketamine in the Asian subgroup was generally consistent with the total SUSTAIN-2 population. There was no new safety signal and no indication of a high potential for abuse with the long-term (up to one year) use of esketamine in the Asian subgroup. Most of the benefits of esketamine occurred early during the induction phase.

Indexed as

AdministrationAntidepressive agentsAsiaDepressive disorderEsketamineintranasaltreatment-resistant

Identifiers

PMID35078950
PMCPMC8813327

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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.