Summary of findings 2. Ketamine compared to midazolam for adults with unipolar major depressive disorder.
| Ketamine compared to Midazolam for adults with unipolar major depressive disorder | ||||||
| Patient or population: adults (aged 18 years+) with unipolar major depressive disorder Setting: any setting (outpatient, inpatient, or both) Intervention: ketamine Comparison: midazolam | ||||||
| Outcomes | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | Certainty of the evidence (GRADE) | What happens | ||
| Without ketamine | With ketamine | Difference | ||||
| Efficacy: number of participants who respond to treatment ‐ at 24 hours assessed with: HAM‐D‐6, HAM‐D‐17, MADRS № of participants: 296 (4 RCTs) | OR 2.48 (1.00 to 6.18) | Study population | ⊕⊝⊝⊝ VERY LOW 1 2 3 | |||
| 25.9% | 46.5% (25.9 to 68.4) | 20.5% more (0 fewer to 42.5 more) | ||||
| Efficacy: number of participants who achieve remission ‐ at 24 hours assessed with: MADRS № of participants: 122 (2 RCTs) | OR 2.21 (0.67 to 7.32) | Study population | ⊕⊕⊝⊝ LOW 2 3 | |||
| 18.0% | 32.7% (12.8 to 61.6) | 14.7% more (5.2 fewer to 43.6 more) | ||||
| Depression rating scale score ‐ at 24 hours assessed with: MADRS № of participants: 297 (4 RCTs) | ‐ | ‐ | ‐ | SMD 0.49 lower (0.87 lower to 0.1 lower) | ⊕⊝⊝⊝ VERY LOW 1 2 3 | |
| Acceptability: total dropouts № of participants: 72 (1 RCT) | OR 0.33 (0.05 to 2.09) | Study population | ⊕⊕⊝⊝ LOW 4 | |||
| 12.0% | 4.3% (0.7 to 22.2) | 7.7% fewer (11.3 fewer to 10.2 more) | ||||
| Acceptability: dropouts due to adverse effects ‐ not reported | ‐ | ‐ | ‐ | ‐ | ||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval;HAM‐D: Hamilton Depression Rating Scale; MADRS: Montgomery‐Asberg Depression Rating Scale;OR: Odds ratio; RCT: randomised controlled trial; SMD: standardised mean difference. | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect. | ||||||
1 Downgraded by two points due to the majority of trials being unclear or high risk regarding the blinding of outcome assessments.
2 Downgraded by one point due to moderately large heterogeneity (I2 value = 30% to 60%).
3 Downgraded by one point due to the low number of participants available for this outcome and the associated width of the confidence intervals.
4 Downgraded by two points due to the very low number of participants available for this outcome and the associated width of the confidence intervals.