Jarventausta 2013.
| Study characteristics | ||
| Methods | Double‐blind randomised controlled trial | |
| Participants |
Diagnosis: DSM‐IV severe or psychotic major depressive disorder; an inadequate response to at least two therapeutic trials of an antidepressant Diagnosis of psychotic depression: S‐ketamine group = 31.3%; saline group = 31.3% N: 32 Age: S‐ketamine group M = 48.8 (range = 23‐81); saline group M = 53.7 (range 24‐81) Sex: S‐ketamine group 50% female; saline group 68.7% female Baseline depression severity: S‐ketamine group MADRS = 36.9 (range = 31‐50); saline group MADRS = 37.3 (range = 27‐49) |
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| Interventions | S‐ketamine (N = 16) 0.4 mg/kg as a bolus Saline (N = 16) Following S‐ketamine or saline, all patients received an initial bolus of 0.5 mg/kg propofol, then given using a dose‐titration (mean dose = 99.5 mg/kg) Patients received ECT sessions three times a week until they reached remission (MADRS score ≤ 7) or no further symptom reduction was achieved during the last 2 ECT sessions Concomitant treatment: Yes, patients remained on existing psychotropic medication |
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| Outcomes | MADRS Response rates (≥ 50% reduction in MADRS scores) Remission rates (≤ 7 on MADRS) BDI |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details given on randomisation procedure, simply ''randomized'' |
| Allocation concealment (selection bias) | Unclear risk | No details given on allocation concealment procedure |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details given on blinding of participants and personnel |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: ''all the rating were done blindly to S‐ketamine by experienced nurses'' |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Requested data to authors (waiting for a reply) |
| Selective reporting (reporting bias) | Unclear risk | Protocol unavailable. Requested data to authors (waiting for a reply) |
| Other bias | Low risk | No other potential sources of bias identified |