Management of bipolar I depression: clinical utility of lurasidone

Figures & data

Figure 1 The efficacy outcome at the end of 6 weeks of treatment of acutely depressed type I bipolar patients treated with placebo, or monotherapy with lurasidone 20–60 mg/day, or lurasidone 80–120 mg/day.

Notes: The effect size for the low dose arm is 0.61, and for the high dose arm 0.50; these are considered medium in size. P-values are versus placebo arm.
Abbreviation: MADRS, Montgomery–Ȧsberg Depression Rating Scale.

Figure 2 The efficacy outcome at the end of 6 weeks of treatment of acutely depressed type I bipolar patients treated with lithium or valproate to which either placebo was added or lurasidone 20–80 mg/day.

Notes: The effect size is 0.34. P-values are versus placebo arm.
Abbreviations: Li, lithium; VPA, valproate; MADRS, Montgomery–Ȧsberg Depression Rating Scale.

Table 1 Spontaneously reported adverse events (AEs) in the three registrational trials for lurasidone

Event	Low dose (n=164)	High dose (n=167)	Placebo (n=168)	Li/VPA + lurasidone (n=360)	Li/VPA + placebo (n=334)
Tremor				18.2%	4.3%
Nausea	10.4%	17.4%	7.7%	17.5%	11.0%
Somnolence	7.3%	13.8%	6.5%	8.7%	4.3%
Headache				10.4%	12.3%
Akathisia	7.9%	10.8%	2.4%
Insomnia				7.1%	5.5%
Dry mouth	6.1%	3.6%	4.2%
Diarrhea	4.9%	3.0%	1.8%	4.4%	6.7%
Discontinuation due to AE	7.0%	6.0%	6.0%	7.9%	6.0%

Notes: Only AEs occurring at ≥5% are reported. The United States Food and Drug Administration does not perform statistical analysis on AEs. Low dose = lurasidone 20–60 mg/day; High dose = lurasidone 80–120 mg/day; Li/VPA + lurasidone = lurasidone 20–80 mg added to lithium or valproate; Li/VPA + placebo = placebo added to lithium or valproate.

Abbreviations: Li, lithium; VPA, valproate.