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

Grunebaum 2018.

Study characteristics
Methods Randomised, double‐blind, controlled trial
Participants Diagnosis: DSM‐IV major depressive episode
N: 80
Age: ketamine 0.5 mg/kg group M = 38.4 (SD = 13.2); midazolam 0.02 mg/kg group M = 40.7 (SD = 13.1)
Sex: ketamine 0.5 mg/kg group 55% female; midazolam 0.02 mg/kg group 65% female
Baseline depression severity: ketamine 0.5 mg/kg group HAM‐D score M = 22.2 (SD = 4.6); midazolam 0.02 mg/kg group HAM‐D score M = 22.6 (SD = 3.9)
Interventions Participants were given intravenous racemic ketamine hydrochloride at 0.5 mg/kg or midazolam at 0.02 mg/kg in 100 mL normal saline infused over 40 minutes.
Ketamine 0.5 mg/kg group (N = 40)
Midazolam 0.02 mg/kg group (N = 40)
Concomitant treatment: yes, participants were allowed to continue on stable dosages of current psychiatric medications, except that benzodiazepines could not be taken within 24 hours before the infusion.
Outcomes HAM‐D
SSI
BDI
Profile of Mood States (POMS)
CADSS
BPRS
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "A permuted, blocked design was used, with 1:1 assignment between treatments and block size randomized between 4 and 6 with equal probability. Randomization was stratified on two baseline factors"
Allocation concealment (selection bias) Unclear risk No information given on allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No further information given beyond, quote: "Patients and study personnel were blinded to treatment." Stated but not tested.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No further information given beyond, quote:"Patients and study personnel were blinded to treatment."
Incomplete outcome data (attrition bias)
All outcomes Low risk Withdrawal and drop out rates reported.
Selective reporting (reporting bias) Unclear risk Protocol not available
Other bias Low risk No other potential sources of bias identified