Grunebaum 2018.
Study characteristics | ||
Methods | Randomised, double‐blind, controlled trial | |
Participants |
Diagnosis: DSM‐IV major depressive episode
N: 80 Age: ketamine 0.5 mg/kg group M = 38.4 (SD = 13.2); midazolam 0.02 mg/kg group M = 40.7 (SD = 13.1) Sex: ketamine 0.5 mg/kg group 55% female; midazolam 0.02 mg/kg group 65% female Baseline depression severity: ketamine 0.5 mg/kg group HAM‐D score M = 22.2 (SD = 4.6); midazolam 0.02 mg/kg group HAM‐D score M = 22.6 (SD = 3.9) |
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Interventions | Participants were given intravenous racemic ketamine hydrochloride at 0.5 mg/kg or midazolam at 0.02 mg/kg in 100 mL normal saline infused over 40 minutes. Ketamine 0.5 mg/kg group (N = 40) Midazolam 0.02 mg/kg group (N = 40) Concomitant treatment: yes, participants were allowed to continue on stable dosages of current psychiatric medications, except that benzodiazepines could not be taken within 24 hours before the infusion. |
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Outcomes | HAM‐D SSI BDI Profile of Mood States (POMS) CADSS BPRS |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A permuted, blocked design was used, with 1:1 assignment between treatments and block size randomized between 4 and 6 with equal probability. Randomization was stratified on two baseline factors" |
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 given beyond, quote: "Patients and study personnel were blinded to treatment." Stated but not tested. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No further information given beyond, quote:"Patients and study personnel were blinded to treatment." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawal and drop out rates reported. |
Selective reporting (reporting bias) | Unclear risk | Protocol not available |
Other bias | Low risk | No other potential sources of bias identified |