Exploring vortioxetine combination with intranasal esketamine: A feasible alternative to SSRI/SNRI? - Insights from the REAL-ESK study

J Affect Disord. 2024 Dec 15:367:583-588. doi: 10.1016/j.jad.2024.09.004. Epub 2024 Sep 2.

Abstract

Background: Treatment-Resistant Depression (TRD) affects almost 30 % of patients with Major Depressive Disorder (MDD). Esketamine Nasal Spray (ESK-NS) has recently been approved for TRD in combination with a Serotonin Specific Reuptake Inhibitor/SSRI or a Serotonin-Norepinephrine Reuptake Inhibitor/SNRI. There is a lack of studies investigating the effectiveness and safety of ESK-NS in combination with other oral antidepressants.

Aim: To assess the efficacy of Vortioxetine plus ESK-NS in mitigating depressive symptoms and emotional blunting, as well as its tolerability in TRD subjects, compared to the standard-of-care of SSRI/SNRI plus ESK-NS.

Methods: We conducted a post-hoc analysis of the REAL-ESK study. The study included twenty TRD patients, ten subjects taking Vortioxetine as the main oral antidepressant with ESK-NS, and ten subjects taking SSRI or SNRI with ESK-NS. Psychometric assessments (Montgomery-Åsberg Depression Rating Scale/MADRS, Brief Psychiatric Rating Scale/BPRS) were conducted at baseline(T0), one month(T1), and three months after the treatment initiation(T2).

Results: The combination of Vortioxetine and ESK-NS was as effective as the standard-of-care in reducing depressive symptoms, with a higher effect size in reducing emotional blunting at T2. The safety and tolerability profile of the Vortioxetine+ESK-NS combination appeared to be better, with a lower rate of treatment-emergent adverse events.

Conclusion: The combination of Vortioxetine and ESK-NS may be a valuable alternative to the standard-of-care SSRI/SNRI plus ESK-NS in TRD patients, particularly regarding the reduction of emotional blunting and potentially a better safety and tolerability profile. Further randomized controlled trials with larger sample sizes and prospective designs are needed to confirm these findings.

Keywords: Depression; ESK-NS; Emotional blunting; Glutamate; TRD; Vortioxetine.

MeSH terms

  • Administration, Intranasal*
  • Adult
  • Antidepressive Agents* / administration & dosage
  • Antidepressive Agents* / therapeutic use
  • Depressive Disorder, Major* / drug therapy
  • Depressive Disorder, Treatment-Resistant* / drug therapy
  • Drug Therapy, Combination*
  • Female
  • Humans
  • Ketamine* / administration & dosage
  • Ketamine* / adverse effects
  • Male
  • Middle Aged
  • Psychiatric Status Rating Scales
  • Selective Serotonin Reuptake Inhibitors* / administration & dosage
  • Serotonin and Noradrenaline Reuptake Inhibitors / administration & dosage
  • Serotonin and Noradrenaline Reuptake Inhibitors / pharmacology
  • Treatment Outcome
  • Vortioxetine* / administration & dosage

Substances

  • Vortioxetine
  • Ketamine
  • Selective Serotonin Reuptake Inhibitors
  • Esketamine
  • Antidepressive Agents
  • Serotonin and Noradrenaline Reuptake Inhibitors