Summary of findings 6. Riluzole compared to placebo for adults with depression in bipolar disorder.

Riluzole compared to placebo 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: riluzole Comparison: placebo
Outcomes	Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Risk with placebo	Risk with riluzole
Efficacy: number of participants who respond to treatment ‐ not reported	‐	‐	‐	‐	‐
Efficacy: number of participants who achieve remission ‐ not reported	‐	‐	‐	‐	‐
Depression rating scale scores ‐ not reported	‐	‐	‐	‐	‐
Acceptability: total dropouts	Study population		OR 2.00 (0.31 to 12.84)	19 (1 RCT)	⊕⊝⊝⊝ VERY LOW 1 2
	455 per 1,000	625 per 1,000 (205 to 915)
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; 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 trial ending prematurely.

² Downgraded by two points because of small sample size overall and wide confidence intervals across the line of no difference.