The efficacy and safety of adjunctive intranasal esketamine treatment in major depressive disorder: a systematic review and meta-analysis

References

• GBD Results Tool | gHDx [Internet]. cited 2021 Dec 7. Available from: http://ghdx.healthdata.org/gbd-results-tool?params=gbd-api-2019-permalink/d780dffbe8a381b25e1416884959e88b.
   Google Scholar
• Johnston KM, Powell LC, Anderson IM, et al. The burden of treatment-resistant depression: a systematic review of the economic and quality of life literature. J Affect Disord. 2019;242:195–210.
   PubMed Web of Science ®Google Scholar
• McIntyre RS, Lee Y, Mansur RB. Treating to target in major depressive disorder: response to remission to functional recovery. CNS Spectr. 2015;20(S1):17–31.
   Google Scholar
• McIntyre RS, Cha DS, Soczynska JK, et al. Cognitive deficits and functional outcomes in major depressive disorder: determinants, substrates, and treatment interventions. Depress Anxiety. 2013;30(6):515–527.
   PubMed Web of Science ®Google Scholar
• Souery D, Papakostas GI, Trivedi MH. Treatment-resistant depression. J Clin Psychiatry. 2006;67(Suppl 6):16–22.
   PubMed Web of Science ®Google Scholar
• Commissioner O of the. FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic [Internet]. FDA. FDA; 2020 cited 2021 Dec 7. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified.
   Google Scholar
• Sanacora G, Schatzberg AF. Ketamine: promising path or false prophecy in the development of novel therapeutics for mood disorders? Neuropsychopharmacology. 2015;40(2):259–267.
   PubMed Web of Science ®Google Scholar
• Zanos P, Gould TD. Mechanisms of ketamine action as an antidepressant. Mol Psychiatry. 2018;23(4):801–811.
   PubMed Web of Science ®Google Scholar
• Xiong J, Lipsitz O, Chen-Li D, et al. The acute antisuicidal effects of single-dose intravenous ketamine and intranasal esketamine in individuals with major depression and bipolar disorders: a systematic review and meta-analysis. J Psychiatr Res. 2021;134:57–68.
   PubMed Web of Science ®Google Scholar
• McIntyre RS, Rosenblat JD, Nemeroff CB, et al. Synthesizing the evidence for Ketamine and Esketamine in treatment-resistant depression: an international expert opinion on the available evidence and implementation. Am J Psychiatry. 2021;178(5):383–399.
   PubMed Web of Science ®Google Scholar
• Wang S-M, Kim N-Y, H-r N, et al. Rapid onset of intranasal Esketamine in patients with treatment resistant depression and major depression with suicide ideation: a meta-analysis. Clin Psychopharmacol Neurosci Off Sci J Korean Coll Neuropsychopharmacol. 2021;19(2):341–354.
   PubMed Web of Science ®Google Scholar
• Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71.
   PubMed Web of Science ®Google Scholar
• Cohen J. Statistical power analysis for the behavioral sciences. Rev. ed. Hillsdale [NJ US]: Erlbaum; 1977. p. xv, 474.
   Google Scholar
• Schünemann HJ, Higgins JP, Vist GE, et al. Completing ‘Summary of findings’ tables and grading the certainty of the evidence. Cochrane Handb Syst Rev Interv [Internet]. John Wiley & Sons, Ltd; 2019 [cited 2021 Dec 26]. p. 375–402. Available from: https://onlinelibrary.wiley.com/doi/abs/10.1002/9781119536604.ch14.
   Google Scholar
• Deeks JJ, Higgins JP, Altman DG. Analysing data and undertaking meta-analyses. Cochrane Handb Syst Rev Interv [Internet]. John Wiley & Sons, Ltd; 2008 [cited 2021 Dec 26]. p. 243–296. Available from: https://onlinelibrary.wiley.com/doi/abs/10.1002/9780470712184.ch9.
   Google Scholar
• Sterne JAC, Savović J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898.
   PubMed Web of Science ®Google Scholar
• Sterne JA, Hernán MA, Reeves BC, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ. 2016;355:i4919.
   PubMed Web of Science ®Google Scholar
• Ochs-Ross R, Daly EJ, Zhang Y, et al. Efficacy and safety of Esketamine nasal spray plus an oral antidepressant in elderly patients with treatment-resistant depression-TRANSFORM-3. Am J Geriatr Psychiatry Off J Am Assoc Geriatr Psychiatry. 2020;28(2):121–141.
   PubMed Web of Science ®Google Scholar
• Takahashi N, Yamada A, Shiraishi A, et al. Efficacy and safety of fixed doses of intranasal Esketamine as an add-on therapy to Oral antidepressants in Japanese patients with treatment-resistant depression: aphase 2b randomized clinical study. BMC Psychiatry. 2021;21(1):526.
   PubMed Web of Science ®Google Scholar
• Fedgchin M, Trivedi M, Daly EJ, et al. Efficacy and safety of fixed-dose Esketamine nasal spray combined with a new oral antidepressant in treatment-resistant depression: results of a randomized,double-blind,active-controlled study (TRANSFORM-1). Int J Neuropsychopharmacol. 2019;22(10):616–630.
   PubMed Web of Science ®Google Scholar
• Popova V, Daly EJ, Trivedi M, et al. Efficacy and safety of flexibly dosed Esketamine nasal spray combined with a newly initiated oral antidepressant in treatment-resistant depression: a randomized double-blind active-controlled study. Am J Psychiatry. 2019;176(6):428–438.
   PubMed Web of Science ®Google Scholar
• Canuso CM, Singh JB, Fedgchin M, et al. Efficacy and safety of intranasal esketamine for the rapid reduction of symptoms of depression and suicidality in patients at imminent risk for suicide: results of a double-blind, randomized,placebo-controlled study. Am J Psychiatry. 2018;175(7):620–630.
   PubMed Web of Science ®Google Scholar
• Daly EJ, Trivedi MH, Janik A, et al. Efficacy of Esketamine nasal spray plus oral antidepressant treatment for relapse prevention in patients with treatment-resistant depression: a randomized clinical trial. JAMA Psychiatry. 2019;76(9):893–903.
   PubMed Web of Science ®Google Scholar
• Ionescu DF, D-J F, Qiu X, et al. Esketamine nasal spray for rapid reduction of depressive symptoms in patients with major depressive disorder who have active suicide ideation with intent: results of aphase 3,double-blind, randomized study (ASPIRE II). Int J Neuropsychopharmacol. 2021;24(1):22–31.
   PubMed Web of Science ®Google Scholar
• Fu DJ, Ionescu DF, Li X, et al. Esketamine nasal spray for rapid reduction of major depressive disorder symptoms in patients who have active suicidal ideation with intent: double-blind, randomized study (ASPIRE I). J Clin Psychiatry. 2020;81(3):19m13191.
   Web of Science ®Google Scholar
• Wajs E, Aluisio L, Holder R, et al. Esketamine nasal spray plus oral antidepressant in patients with treatment-resistant depression: assessment of long-term safety in a phase 3, open-label study (SUSTAIN-2). J Clin Psychiatry. 2020;81(3):19m12891.
   Web of Science ®Google Scholar
• Higgins JPT, Thomas J, Chandler J, et al. Cochrane handbook for systematic reviews of interventions [Internet]. cited 2021 Aug 6]. Available from 2021 Aug 6: https://training.cochrane.org/handbook.
   Google Scholar
• Ionescu DF, Rosenbaum JF, Alpert JE. Pharmacological approaches to the challenge of treatment-resistant depression. Dialogues Clin Neurosci. 2015;17:111–126.
   PubMed Web of Science ®Google Scholar
• McIntyre RS, Filteau M-J, Martin L, et al. Treatment-resistant depression: definitions, review of the evidence, and algorithmic approach. J Affect Disord. 2014;156:1–7.
   PubMed Web of Science ®Google Scholar
• Strawbridge R, Carter B, Marwood L, et al. Augmentation therapies for treatment-resistant depression: systematic review and meta-analysis. Br J Psychiatry J Ment Sci. 2019;214(1):42–51.
   PubMed Web of Science ®Google Scholar
• Cha DS, McIntyre RS. Treatment-emergent adverse events associated with atypical antipsychotics. Expert Opin Pharmacother. 2012;13(11):1587–1598.
   PubMed Web of Science ®Google Scholar
• A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials | molecular psychiatry [Internet]. cited 2022 Jan 11]. Available from 2022 Jan 11: https://www.nature.com/articles/s41380-021-01381-x.
   Google Scholar
• Rong C, Park C, Rosenblat JD, et al. Predictors of response to ketamine in treatment resistant major depressive disorder and bipolar disorder. Int J Environ Res Public Health. 2018;15(4):E771.
   PubMed Web of Science ®Google Scholar
• Kautzky A, Dold M, Bartova L, et al. Clinical factors predicting treatment resistant depression: affirmative results from the European multicenter study. Acta Psychiatr Scand. 2019;139(1):78–88.
   PubMed Web of Science ®Google Scholar
• Cepeda MS, Reps J, Ryan P. Finding factors that predict treatment‐resistant depression: results of a cohort study. Depress Anxiety. 2018;35(7):668–673.
   PubMed Web of Science ®Google Scholar
• Proudman D, Greenberg P, Nellesen D. The growing burden of major depressive disorders (MDD): implications for Researchers and policy makers. PharmacoEconomics. 2021;39(6):619–625.
   PubMed Web of Science ®Google Scholar
• The meaningful change threshold as measured by the 16-item quick inventory of depressive symptomatology in adults with treatment-resistant major depressive and bipolar disorder receiving intravenous ketamine - ScienceDirect [Internet]. cited 2022 Jan 11]. Available from 2022 Jan 11: https://www.sciencedirect.com/science/article/abs/pii/S016503272100714X?via%3Dihub.
   Google Scholar
• Kasper S, Cubała WJ, Fagiolini A, et al. Practical recommendations for the management of treatment-resistant depression with esketamine nasal spray therapy: basic science, evidence-based knowledge and expert guidance. World J Biol Psychiatry Off J World Fed Soc Biol Psychiatry. 2021;22(6):468–482.
   PubMed Web of Science ®Google Scholar
• McIntyre RS, Berk M, Brietzke E, et al. Bipolar disorders. Lancet. 2020;396(10265):1841–1856.
   PubMed Web of Science ®Google Scholar
• Wilkinson ST, Wright D, Fasula MK, et al. Cognitive behavior therapy may sustain antidepressant effects of intravenous ketamine in treatment-resistant depression. Psychother Psychosom. 2017;86(3):162–167.
   PubMed Web of Science ®Google Scholar