Su 2017.
Study characteristics | ||
Methods | Double‐blind, randomised, parallel‐group, placebo controlled trial | |
Participants |
Diagnosis: DSM‐IV major depressive disorder N: 71 Age: ketamine 0.5 mg/kg group M = 48.5 (SD = 11.0); ketamine 0.2 mg/kg group M = 45.0 (SD = 12.3); placebo group M = 48.6 (SD = 8.2) Sex: ketamine 0.5 mg/kg group 87.5% female; ketamine 0.2 mg/kg 73.9% female; placebo group 62.5% female Baseline depression severity: ketamine 0.5 mg/kg group HAMD‐17 score M = 23.0 (SD = 4.9); ketamine 0.2 mg/kg group HAMD‐17 score M = 23.1 (SD = 4.8); placebo group HAMD‐17 score M = 23.3 (SD = 4.1) |
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Interventions | Patients were randomised to receive a 40‐minute intravenous infusion ketamine (0.2 mg/kg or 0.5 mg/kg) or saline. | |
Outcomes | HAMD‐17 MADRS BDI Blood pressure Heart rate Digit pulse oximetry Response (≥ 50% reduction of HAMD‐17 score at any two daily HAMD measures during the period of 24 to 96 hours (days 2 to 5) after infusion. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details on randomisation procedures given |
Allocation concealment (selection bias) | Unclear risk | No details on allocation concealment given |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Stated but not tested |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details about blinding of outcome assessment given |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Consort flow diagram with details of attrition included in figure 1 (page 2843) |
Selective reporting (reporting bias) | Low risk | Trial registration available online (UMIN000016985). Outcomes all reported. |
Other bias | Low risk | None identified |