Ionescu 2020.
| Study characteristics | ||
| Methods | Double‐blind, randomised, placebo‐controlled, multicentre study | |
| Participants |
Diagnosis: DSM‐5 major depressive disorder with suicidal ideation
N: 230 Age: esketamine M = 40.2 (SD=12.72); placebo M = 41.4 (SD = 13.43) Sex: esketamine 60.5% female; placebo 59.3% female Baseline depression severity: esketamine group MADRS M = 39.5 (SD = 5.19); placebo group MADRS M = 39.9 (SD = 5.76) |
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| Interventions | Participants were randomised to receive either 84 mg esketamine nasal spray or matching placebo nasal spray twice weekly for 4 weeks. Concomitant medications: all participants received standard‐of‐care oral antidepressant(s) initiated or optimised at randomisation. |
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| Outcomes | MADRS CGI‐SS‐r Response Remission Adverse events |
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| Notes | Authors kindly provided additional data for remission rates according to this review's definition, MADRS and CGI‐SS‐r scores. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Eligible patients were randomized (1:1) to 84 mg esketamine nasal spray or matching placebo nasal spray according to a computer‐generated schedule". |
| Allocation concealment (selection bias) | Low risk | Quote: "Eligible patients were randomized (1:1) to 84 mg esketamine nasal spray or matching placebo nasal spray according to a computer‐generated schedule". |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Stated but not tested. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Different raters were used for efficacy and safety ratings, however it is likely patients were unblinded by dissociative side effects of esketamine. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Flow diagram of participants throughout study included. Participant withdrawal rate reported, similar between groups. |
| Selective reporting (reporting bias) | Low risk | Trial registered (NCT03097133), outcomes reported as expected. |
| Other bias | High risk | Study funded by and authors employed by pharmaceutical company. |