Long-term use of lurasidone in patients with bipolar disorder: safety and effectiveness over 2 years of treatment

International Journal of Bipolar Disorders

Table 1 Baseline demographic and clinical characteristics of patient sample at 18-month continuation study baseline (safety population)

Characteristic	Lurasidone (N = 122)
Characteristic	N	%
Male	64	52.5
Race
White	71	58.2
Black/African–American	3	2.5
Asian	32	26.2
Other	16	13.1
History of rapid cycling (≥ 4 episodes in past 12 months)	7	5.7
Adjunctive mood stabilizer, n (%) ^a
Yes	93	76.2
No	29	23.8

Characteristic	Lurasidone (N = 122)
Characteristic	Mean	SD
Age, years	41.3	12.2
Age at initial bipolar diagnosis, years	31.3	11.8
Duration of depressive episode (at entry into DB study), weeks	10.8	7.2
MADRS total score
Acute double-blind baseline	28.8	4.4
6-month extension baseline	13.8	8.7
18-month continuation study baseline	6.5	5.3
CGI-severity score ^b
Acute double-blind baseline	4.3	0.5
6-month extension baseline	2.8	1.0
18-month continuation study baseline	2.1	1.0

^a In acute double-blind (DB) study
^b Note that the CGI-BP-S scale was used to assess severity at Baseline of the acute DB and 6-month extension studies