Chen 2017.
Study characteristics | ||
Methods | Randomised, placebo‐controlled, double‐blind trial | |
Participants |
Diagnosis: DSM‐IV‐TR major depressive episode
N: 132 randomised, 127 completed the study Age: ketamine 0.3 mg/kg group M = 40.94 (SD = 15.41); placebo saline group M = 37.44 (SD = 14.16) Sex: ketamine 0.3 mg/kg group 66.7% female; placebo saline group 64.1% female Baseline depression severity: ketamine 0.3mg/kg group HAM‐D score M = 38.05 (SD = 3.23); placebo saline group HAM‐D score M = 37.43 (SD = 2.64) |
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Interventions | Patients assigned to the study group were anesthetised using 1.5 mg/kg propofol and 0.3 mg/kg ketamine delivered intravenously. Patients assigned to the control group were anesthestised using 1.5 mg/kg propofol and normal saline. The ECT was administered 3 times a week (12 sessions of ECT in total). Ketamine 0.3 mg/kg group (N = 63) Placebo saline group (N = 64) Concomitant treatment: Not reported |
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Outcomes | Wechsler Memory Scale‐Chinese Revision (WMS‐RC) MMSE HAM‐D Remission rates (sustained HAM‐D score <10 after 2 consecutive ECTs) 4‐item positie symptom subscale of the Brief Psychatric Rating Scale (BPRS+) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "All recruited participants were randomly assigned into 1 of 2 groups: the control group and the study group. Half the patients were placed in each group using a computer‐generated random number table." No further details given. |
Allocation concealment (selection bias) | Low risk | Quote: "The patients, treatment teams, and the outcome assessors were all blinded to the intervention allocation." |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding stated but not tested. Quote: "The anesthesiologists, patients, and outcome raters were all blind to the group assignments and the anesthetic regimen." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding stated but not tested. Ketamine and normal saline were both prepared before each ECT treatment, quote: "by a specialized nurse who was blind to the study design". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Exclusion and withdrawal rates at each time point are recorded |
Selective reporting (reporting bias) | Unclear risk | Protocol unavailable |
Other bias | Low risk | No other potential sources of bias identified |