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) |
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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. |
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Outcomes | HRSD Cognitive Performance Recovery Time |
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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Incomplete outcome data (attrition bias) All outcomes | Low risk | Numbers of withdrawn participants and reasons for withdrawal reported.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 |