Loo 2012.
| Study characteristics | ||
| Methods | Double‐blind randomised controlled trial | |
| Participants |
Diagnosis: DSM‐IV major depressive episode (9 bipolar disorder, depressed)
N: 46 Age: ketamine group = 45.2 (SD = 15.6); placebo group = 41.4 (SD = 12.0) Sex: ketamine group 50% female; placebo group 71% female Baseline depression severity: ketamine group MADRS = 32.1 (SD = 4.5); placebo group MADRS = 32.7 (SD = 7.9) |
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| Interventions | All patients first received ECT 3 times a week. After induction of unconsciousness with IV thiopentone (3‐5mg/kg), patients randomly assigned to ketamine or placebo Ketamine (N = 26) 0.5 mg/kg IV Placebo (N = 25) saline The same procedure was followed for all ECT treatment sessions. A mean dose of 40.2 mg/kg (SD = 8.0) was delivered in the ketamine group Concomitant treatment: yes, 19 patients remained on medications during ECT and 3 commenced new medication in 2 weeks prior to beginning ECT |
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| Outcomes | MADRS
Response rate (not defined) Remission rate (not defined) Adverse events Neuropsychological outcomes |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: ''Participants were randomly assigned (by computer‐generated random number sequence)'' |
| Allocation concealment (selection bias) | Low risk | Quote: ''Participants and clinical staff other than the ECT anaesthetist were masked to treatment condition'' |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: ''Participants and clinical staff other than the ECT anaesthetist were masked to treatment condition... The integrity of blinding was not formally assessed but there were no indications that participants or raters were aware of the treatment assignment (as reported during ratings interviews), apart from one participant who was withdrawn because she was inadvertently unblinded." |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details given on blinding of outcome assessment |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Not all participants followed up at 1 week post‐ECT. Dropout rates provided in published article do not match up with those provided by author |
| Selective reporting (reporting bias) | Unclear risk | Protocol unavailable, but all outcomes fully reported |
| Other bias | Low risk | No other potential sources of bias identified |