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. 2021 Sep 12;2021(9):CD011612. doi: 10.1002/14651858.CD011612.pub3

Correia‐Melo 2020.

Study characteristics
Methods Randomised, double‐blind, active‐controlled, bicentre, noninferiority clinical trial, with two parallel groups.
Participants Diagnosis: DSM‐IV MDD diagnosis
N: 63
Age: esketamine M = 45.5 (SD=14.5); Ketamine = 48.7 (SD=15.1)
Sex: esketamine = 55.8% female (N = 19); ketamine = 70.3% female (N = 19).
Baseline depression severity: MADRS score esketamine M = 3.1 (SD = 9.3); MADRS score ketamine M = 32.9 (SD = 5.3)
Interventions Participants were randomised on a 1:1 ratio into two groups of either ketamine (Clortamina®, BioChimico, 10 mL ampoules, 50 mg/mL and dose: 0.5 mg/kg) or esketamine (Ketamin®, Cristália, 2 mL ampoules, 50 mg/mL and dose: 0.25 mg/kg). Both drugs were diluted in 100ml saline and administered intravenously over 40 minutes.
Outcomes MADRS Response Rate
Adverse events
CADSS
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Participants were randomized on a 1:1 ratio into two groups of either ketamine (Clortamina®, BioChimico, 10 mL ampoules, 50 mg/mL and dose: 0.5 mg/kg) or esketamine (Ketamin®, Cristália, 2 mL ampoules, 50 mg/mL and dose: 0.25 mg/kg, through an electronic randomization platform (http://www.randomizer.org) (Urbaniak and Plous, 2013)."
Allocation concealment (selection bias) Low risk Quote: "Only the single investigator, who was responsible for both centres’ randomization and allocation processes, and the nurse responsible for drug preparation, were aware of the drug being infused."
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Blinding stated but not tested
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "All assessments were conducted by investigators blind to treatment allocation.”
Incomplete outcome data (attrition bias)
All outcomes Low risk Numbers included same as numbers in outcome data.
Selective reporting (reporting bias) Low risk Protocol expected outcomes are reported as planned
Other bias Low risk None identified.