PMID- 32860422
OWN - NLM
STAT- MEDLINE
DCOM- 20210521
LR  - 20210521
IS  - 1532-6535 (Electronic)
IS  - 0009-9236 (Print)
IS  - 0009-9236 (Linking)
VI  - 109
IP  - 2
DP  - 2021 Feb
TI  - Benefit-Risk Assessment of Esketamine Nasal Spray vs. Placebo in 
      Treatment-Resistant Depression.
PG  - 536-546
LID - 10.1002/cpt.2024 [doi]
AB  - 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.
CI  - (c) 2020 Janssen. Clinical Pharmacology & Therapeutics published by Wiley 
      Periodicals LLC on behalf of American Society for Clinical Pharmacology and 
      Therapeutics.
FAU - Katz, Eva G
AU  - Katz EG
AD  - Janssen Research & Development, LLC, Raritan, New Jersey, USA.
FAU - Hough, David
AU  - Hough D
AD  - Janssen Research & Development, LLC, Titusville, New Jersey, USA.
AD  - Former employee of Janssen Research and Development, LLC, Titusville, New Jersey, 
      USA.
FAU - Doherty, Teodora
AU  - Doherty T
AD  - Janssen Research & Development, LLC, Titusville, New Jersey, USA.
FAU - Lane, Rosanne
AU  - Lane R
AD  - Janssen Research & Development, LLC, Titusville, New Jersey, USA.
FAU - Singh, Jaskaran
AU  - Singh J
AD  - Janssen Research & Development, LLC, San Diego, California, USA.
AD  - Neurocrine Biosciences, San Diego, California, USA.
FAU - Levitan, Bennett
AU  - Levitan B
AD  - Janssen Research & Development, LLC, Titusville, New Jersey, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02417064
SI  - ClinicalTrials.gov/NCT02418585
SI  - ClinicalTrials.gov/NCT02422186
SI  - ClinicalTrials.gov/NCT02493868
PT  - Journal Article
PT  - Observational Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20201013
PL  - United States
TA  - Clin Pharmacol Ther
JT  - Clinical pharmacology and therapeutics
JID - 0372741
RN  - 0 (Antidepressive Agents)
RN  - 0 (Nasal Sprays)
RN  - 50LFG02TXD (Esketamine)
RN  - 690G0D6V8H (Ketamine)
SB  - IM
MH  - Administration, Oral
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antidepressive Agents/*administration & dosage
MH  - Depressive Disorder, Treatment-Resistant/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Ketamine/*administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Nasal Sprays
MH  - Prospective Studies
MH  - Risk Assessment
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC7894501
COIS- All authors are employees of Janssen Research & Development, LLC.
EDAT- 2020/08/30 06:00
MHDA- 2021/05/22 06:00
PMCR- 2020/10/13
CRDT- 2020/08/30 06:00
PHST- 2020/04/21 00:00 [received]
PHST- 2020/07/26 00:00 [accepted]
PHST- 2020/08/30 06:00 [pubmed]
PHST- 2021/05/22 06:00 [medline]
PHST- 2020/08/30 06:00 [entrez]
PHST- 2020/10/13 00:00 [pmc-release]
AID - CPT2024 [pii]
AID - 10.1002/cpt.2024 [doi]
PST - ppublish
SO  - Clin Pharmacol Ther. 2021 Feb;109(2):536-546. doi: 10.1002/cpt.2024. Epub 2020 
      Oct 13.