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. |