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

Berman 2000.

Study characteristics
Methods Double‐blind randomised controlled cross‐over trial
Participants Diagnosis: DSM‐IV major depressive episode (1 bipolar disorder, depressed)
N: 9
Age: M = 37 (SD = 10.0)
Sex: 56% female
Baseline depression severity: ketamine group HRSD = 33.0 (SD = 6.7); placebo group HRSD = 26.9 (SD = 5.8)
Interventions 1 single IV infusion
Ketamine (N = 4) 0.5 mg/kg infused over 40 minutes
Placebo (N = 3) saline solution infused over 40 minutes
Concomitant treatment: no, patients had a 2‐week drug‐free period before commencing treatment
Outcomes HRSD
Response rate (≥50% reduction in HRSD scores)
BDI
VAS
BPRS
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details given on randomisation procedure beyond quote: ''four participants were randomly assigned''
Allocation concealment (selection bias) Unclear risk No details given on allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No details given on blinding beyond quote: '''in a randomised, double‐blinded manner''
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No details given on blinding of outcome assessment
Incomplete outcome data (attrition bias)
All outcomes High risk 2/9 participants withdrew to institute antidepressant treatment
Selective reporting (reporting bias) High risk Scores not reported for each measured time point (only baseline and final) and BDI scores missing
Other bias Low risk No other potential sources of bias identified