The impact of lurasidone on functioning and indirect costs in adults with bipolar depression: a post-hoc analysis

Figures & data

Figure 1. Flow diagram. Abbreviations. DB, double-blind, placebo-controlled trial; LUR-LUR, lurasidone-lurasidone; N, sample size; OLE, open-label extension; PBO-LUR, placebo-lurasidone.

Table 1. Patient demographics and clinical characteristics at 6-week double-blind trial baseline.

Characteristic	6-week DB participants		Participants continued or switched to open-label lurasidone monotherapy
	Lurasidone	Placebo	LUR-LUR	PBO-LUR
	(n = 323)	(n = 162)	(n = 210)	(n = 106)
Age, years, mean (SD)	41.7 (12.3)	41.2 (12.5)	42.5 (12.6)	41.1 (12.6)
Female, n (%)	189 (58.5)	87 (53.7)	118 (56.2)	58 (54.7)
Race, n (%)
White	213 (65.9)	107 (66.0)	141 (67.1)	74 (69.8)
Asian	46 (14.2)	28 (17.3)	26 (12.4)	13 (12.3)
Black	46 (14.2)	21 (13.0)	26 (12.4)	13 (12.3)
Other	18 (5.6)	6 (3.7)	17 (8.1)	6 (5.7)
Hispanic or Latino, n (%)	14 (4.3)	8 (4.9)	6 (2.9)	5 (4.7)
Region, n (%)
North America	137 (42.4)	58 (35.8)	80 (38.1)	37 (34.9)
Europe	104 (32.2)	59 (36.4)	78 (37.1)	41 (38.7)
Asia	46 (14.2)	27 (16.7)	26 (12.4)	13 (12.3)
Africa	36 (11.1)	18 (11.1)	26 (12.4)	15 (14.2)
Age at initial onset of bipolar I disorder, years, mean (SD)	27.7 (11.4)	27.4 (10.8)	28.5 (11.9)	26.4 (10.2)
Duration of bipolar depression from onset of current episode, weeks, mean (SD)	11.9 (9.0)	10.6 (6.1)	11.6 (8.8)	11.0 (6.0)

Abbreviations. DB, double-blind, placebo-controlled trial; LUR-LUR, lurasidone-lurasidone; N, number of patients; OLE, open-label extension; PBO-LUR, placebo-lurasidone; SD, standard deviation.

Table 2. Mean changes in SDS total and item scores during 6-week double-blind trial.

	Lurasidone (n = 323)			Placebo (n = 162)			Effect size
	DB baseline, mean (SD)	DB week 6, mean (SD)	LS mean change (SE)	DB baseline, mean (SD)	DB week 6, mean (SD)	LS mean change (SE)
SDS total score	19.7 (5.2)	9.6 (7.2)	−10.8 (0.6)	19.8 (5.0)	12.9 (8.2)	−7.6 (0.8)	0.49***
Work/school	6.5 (2.3)	3.4 (2.6)	−3.4 (0.2)	6.8 (1.8)	4.3 (2.9)	−2.5 (0.3)	0.36**
Social life	6.8 (1.9)	3.2 (2.4)	−3.6 (0.2)	6.6 (1.8)	4.5 (2.9)	−2.3 (0.2)	0.55***
Family life/home responsibilities	6.5 (2.0)	3.1 (2.5)	−3.5 (0.2)	6.6 (1.8)	4.4 (3.0)	−2.3 (0.2)	0.50***
Days lost	2.7 (2.5)	1.1 (1.9)	−1.6 (0.1)	2.7 (2.6)	1.6 (2.2)	−1.0 (0.2)	0.33**
Days unproductive	4.5 (2.3)	2.1 (2.4)	−2.3 (0.2)	4.0 (2.6)	2.9 (2.7)	−1.4 (0.2)	0.45***

Abbreviations. DB, double-blind, placebo-controlled trial; LS, least squares; N, number of patients; SD, standard deviation; SDS, Sheehan Disability Scale; SE, standard error.

Notes: ** indicates significance at p < .01, *** at p < .001. Mean calculated for observed cases. LS mean change from baseline was evaluated using an analysis of covariance model with fixed effects for treatment group, pooled study center, and baseline score as covariates.

Table 3. Mean changes in SDS total and item scores during 6-week double-blind trial and 6-month open-label extension in patients who continued or switched to open-label lurasidone monotherapy.

		LUR-LUR (n = 210)			PBO-LUR (n = 106)
		DB baseline	DB week 6/ OLE baseline	OLE month 6	DB baseline	DB week 6/ OLE baseline	OLE month 6
SDS total score	Mean (SD)	19.8 (5.0)	9.3 (7.1)	5.5 (6.0)	20.3 (4.5)	12.6 (8.2)	5.7 (5.7)
	Mean change from baseline (95% CI)^a	–	−10.6 (−11.8, −9.4)	−3.4 (−4.6, −2.2)	–	−8.0 (−9.8, −6.3)	−6.2 (−8.1, −4.3)
Work/school	Mean (SD)	6.5 (2.2)	3.3 (2.5)	1.9 (2.1)	6.9 (1.7)	4.2 (2.8)	1.9 (2.3)
	Mean change from baseline (95% CI)^a	–	−3.2 (−3.7, −2.8)	−1.2 (−1.7, −0.8)	–	−2.8 (−3.4, −2.2)	−2.0 (−2.7, −1.3)
Social life	Mean (SD)	6.8 (1.9)	3.1 (2.4)	1.9 (2.1)	6.8 (1.7)	4.4 (2.9)	2.1 (2.1)
	Mean change from baseline (95% CI)^a	–	−3.8 (−4.1, −3.4)	−1.0 (−1.4, −0.7)		−2.4 (−3.0, −1.9)	−2.1 (−2.8, −1.5)
Family life/home responsibilities	Mean (SD)	6.5 (1.8)	2.9 (2.4)	1.8 (2.1)	6.7 (1.7)	4.3 (3.0)	2.1 (2.1)
	Mean change from baseline (95% CI)^a	–	−3.6 (−4.0, −3.2)	−1.0 (−1.4, −0.6)	–	−2.4 (−3.0, −1.8)	−1.9 (−2.5, −1.3)
Days lost	Mean (SD)	2.5 (2.5)	0.9 (1.7)	0.6 (1.4)	2.6 (2.5)	1.4 (2.1)	0.6 (1.5)
	Mean change from baseline (95% CI)^a		−1.6 (−2.0, −1.3)	−0.3 (−0.5, −0.0)	–	−1.2 (−1.7, −0.8)	−0.8 (−1.3, −0.4)
Days unproductive	Mean (SD)	4.6 (2.4)	2.0 (2.3)	1.1 (1.8)	4.0 (2.5)	2.8 (2.7)	1.0 (1.6)
	Mean change from baseline (95% CI)^a	–	−2.6 (−3.0, −2.2)	−0.8 (−1.2, −0.4)	–	−1.1 (−1.6, −0.6)	−1.8 (−2.4, −1.3)

Abbreviations. CI, confidence interval; DB, double-blind, placebo-controlled trial; LUR-LUR, lurasidone-lurasidone; N, number of patients; –, not applicable; OLE, open-label extension; PBO-LUR, placebo-lurasidone; SD, standard deviation; SDS, Sheehan Disability Scale.

Notes: ^aMean change is from DB baseline to DB week 6 and from OLE baseline/DB week 6 to OLE month 6. Mean calculated for observed cases. Mean change from baseline calculated for patients with observed scores at both time points.

Figure 2. Average days lost in patients who continued or switched to lurasidone monotherapy for OLE. Abbreviations. DB, double-blind, placebo-controlled trial; LOCF, last observation carried forward; LUR, lurasidone; OLE, open-label extension; PBO, placebo.

Figure 3. Average days unproductive in patients who continued or switched to lurasidone monotherapy for OLE. Abbreviations. DB, double-blind, placebo-controlled trial; LOCF, last observation carried forward; LUR-LUR, lurasidone-lurasidone; OLE, open-label extension; PBO-LUR, placebo-lurasidone.

Figure 4. Average annual indirect costs per patient due to days lost or unproductive during double-blind trial. Notes: Error bars represent one SD from the mean. Abbreviations. DB, double-blind, placebo-controlled trial; ES, effect size; SD, standard deviation.

Data availability statement

This post-hoc analysis used confidential clinical trial data, which are not publicly available.