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

Shams Alizadeh 2015.

Study characteristics
Methods Randomised, double‐blind trial
Participants Diagnosis: DSM‐IV‐TR major depressive disorder
N: 44
Age: ketamine 0.3 mg/kg group M = 34.27 (SD =10.66); placebo saline 5 mL group M = 35.1 (SD=12.44)
Sex: ketamine 0.3mg/kg group 72.7% female; placebo saline 5 mL group 65% female
Baseline depression severity: ketamine 0.3 mg/kg group HRSD score M = 35.4 (SD=6.7); placebo saline 5 mL group HRSD score M = 36.44 (SD=7.17)
Interventions The intervention group received 0.3 mg/kg of ketamine hydrochloride intravenously which was diluted with 5mL of saline. In the control group, ketamine was replaced with 5mL of Normal saline. After 30 seconds, both groups received 0.5 mg of atropine IV, prior to ECT.
Ketamine group (N = 22)
Control group (N = 22)
Concomitant treatments:aAll participants received ECT. Yes, no changes were made in the type and doses of the already prescribed drugs.
Outcomes HRSD
Cognitive Performance Recovery Time
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk No further information beyond, "The patients were allocated randomly using the block randomization method."
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 beyond, "The patients were also blind to the received medication"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "The HRSD scores, vital signs, and duration of reorientation were collected by an author who was blind to group assignment".
Incomplete outcome data (attrition bias)
All outcomes Low risk Numbers of withdrawn participants and reasons for withdrawal reported.
Selective reporting (reporting bias) Unclear risk Protocol unavailable
Other bias Low risk No other potential sources of bias identified