Table 1.

Baseline demographic and clinical characteristics of acute study completers who continued in the extension study (safety population)

	Lurasidone monotherapy (N = 316)		Lurasidone adjunctive therapy (N = 497)
Characteristic	N	%	N	%
Female	176	55.7	251	50.5
Race
White	215	68.0	319	64.2
Black/African‐American	39	12.3	55	11.1
Asian	39	12.3	96	19.3
Other	23	7.3	27	5.4
History of rapid cycling (≥4 episodes in past 12 months)	16	5.0	40	8.0
Adjunctive mood stabilizer, n (%)a
Lithium	6	1.9	196	39.4
Valproateb	1	0.3	301	60.6

	Mean	SD	Mean	SD
Age, years	42.0	12.6	43.1	11.7
Age of onset of diagnosis, years	27.7	11.4	29.3	11.7
Duration of current episode, weeks	11.3	7.9	13.2	9.7
Baseline scores
MADRS
Double‐blind baseline	30.1	5.0	30.0	5.0
Extension baseline	14.8	9.4	15.6	10.4
CGI‐BP‐severity
Double‐blind baseline	4.5	0.6	4.5	0.6
Extension baseline	2.8	1.2	2.9	1.3
HAM‐A
Double‐blind baseline	16.1	6.2	15.7	6.0
Extension baseline	8.4	6.4	8.5	6.3
YMRS
Double‐blind baseline	4.1	2.6	3.6	2.7
Extension baseline	2.4	2.6	2.3	2.7

MADRS,  Montgomery‐Åsberg Depression Rating Scale; CGI‐BP‐S, Clinical Global Impression Bipolar Version Severity of Illness depression score; HAM‐A, Hamilton Rating Scale for Anxiety; YMRS, Young Mania Rating Scale.

^aAny time during the study; note that patients treated with lithium or valproate in one of the two acute adjunctive trials were continued on their mood stabilizer; however, mood stabilizer therapy could be discontinued at the discretion of the investigator; or treatment with a mood stabilizer could be initiated during extension treatment in patients who received monotherapy during the acute trial.

^bValproate treatment included: ergynel chrono, valproic acid, and valpromide.

4 patients provided informed consent and entered the open‐label extension study, but never received study medication, and so were not included in the safety population.