Esketamine nasal spray
The European Medicines Agency has approved esketamine nasal spray, to be used in conjunction with a selective-serotonin reuptake inhibitor or a serotonin-noradrenaline reuptake inhibitor, for treatment-resistant major depression disorder in adults who have not responded to at least two different antidepressants in the current moderate to severe depressive episode. The decision to start treatment should be taken by a psychiatrist and the drug must be self-administered by the patient, who is supervised by a healthcare provider in a clinic or doctor’s office. The patients’ blood pressure should be measured before and after administration. Patients with serious respiratory or heart problems should only use esketamine where facilities for resuscitating patients are immediately available. The efficacy of esketamine was evaluated in three short-term (4-week) clinical trials and one longer-term maintenance-of-effect trial.[198]ClinicalTrials.gov. A study to evaluate the efficacy, safety, and tolerability of fixed doses of intranasal esketamine plus an oral antidepressant in adult participants with treatment-resistant depression (TRANSFORM-1). Apr 2019 [internet publication].
https://clinicaltrials.gov/ct2/show/NCT02417064
[199]ClinicalTrials.gov. A study to evaluate the efficacy, safety, and tolerability of flexible doses of intranasal esketamine plus an oral antidepressant in adult participants with treatment-resistant depression (TRANSFORM-2). Apr 2019 [internet publication].
https://clinicaltrials.gov/ct2/show/NCT02418585
[200]van de Loo AJAE, Bervoets AC, Mooren L, et al. The effects of intranasal esketamine (84 mg) and oral mirtazapine (30 mg) on on-road driving performance: a double-blind, placebo-controlled study. Psychopharmacology (Berl). 2017 Nov;234(21):3175-83.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5660834
http://www.ncbi.nlm.nih.gov/pubmed/28755104?tool=bestpractice.com
[201]ClinicalTrials.gov. A study of intranasal esketamine plus an oral antidepressant for relapse prevention in adult participants with treatment-resistant depression (SUSTAIN-1). Feb 2019 [internet publication].
https://clinicaltrials.gov/ct2/show/NCT02493868
[202]ClinicalTrials.gov. A study to evaluate the effects of a single-dose and repeat-administration of intranasal esketamine on on-road driving in participants with major depressive disorder (DriveSaFe2). Apr 2018 [internet publication].
https://clinicaltrials.gov/ct2/show/NCT02919579
In one of the short-term studies, esketamine nasal spray demonstrated statistically significant effect compared with placebo on the severity of depression, and some effect was seen within 2 days. The two other short-term trials did not show statistically significant effectiveness. In the longer-term maintenance-of-effect trial, esketamine plus an oral antidepressant resulted in a statistically significantly longer time to relapse of depressive symptoms compared with placebo nasal spray plus an oral antidepressant. The most common side effects were disassociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthaesia), anxiety, lethargy, increased blood pressure, vomiting, and feeling drunk.
Non-pharmacological interventions
Other potentially effective interventions for ongoing suicidal ideation include online and mobile telephone applications and formal physical exercise programmes.[203]Witt K, Spittal MJ, Carter G, et al. Effectiveness of online and mobile telephone applications ('apps') for the self-management of suicidal ideation and self-harm: a systematic review and meta-analysis. BMC Psychiatry. 2017 Aug 15;17(1):297.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5558658
http://www.ncbi.nlm.nih.gov/pubmed/28810841?tool=bestpractice.com
[204]Vancampfort D, Hallgren M, Firth J, et al. Physical activity and suicidal ideation: a systematic review and meta-analysis. J Affect Disord. 2018 Jan 1;225:438-48.
http://www.ncbi.nlm.nih.gov/pubmed/28858658?tool=bestpractice.com