Summary of findings 2. Ketamine compared to midazolam for adults with depression in bipolar disorder.
| Ketamine compared to midazolam for adults with depression in bipolar disorder | ||||||
| Patient or population: adults (aged 18 years+) with depression in bipolar disorder Setting: any setting (outpatient, inpatient, or both) Intervention: ketamine Comparison: midazolam | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with midazolam | Risk with ketamine | |||||
| Efficacy: number of participants who respond to treatment ‐ at 24 hours | Study population | OR 3.20 (0.23 to 45.19) | 16 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | ||
| 111 per 1,000 | 286 per 1,000 (28 to 850) | |||||
| Efficacy: number of participants who achieve remission ‐ at 24 hours | Study population | OR 1.33 (0.07 to 25.91) | 16 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | ||
| 111 per 1,000 | 143 per 1,000 (9 to 764) | |||||
| Depression rating scale score ‐ at 24 hours | ‐ | MD 5.85 lower (12.13 lower to 0.43 higher) | ‐ | 16 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | |
| Acceptability: dropouts due to adverse effects at 24 hours | Study population | not estimable | 16 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | ||
| not estimable | not estimable | |||||
| Acceptability: total dropouts | Study population | not estimable | 16 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | ||
| not estimable | not estimable | |||||
| *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; HDRS: Hamilton depression rating scale; OR: Odds ratio. | ||||||
| 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 unclear method of allocation concealment and selective reporting bias.
2 Downgraded by two points due to the very low number of participants available for this outcome and the associated width of the confidence intervals.