TABLE 1.

Demographics, Baseline Clinical Rating, and Psychiatric History (Efficacy Analysis Data Set)

Parameter	Placebo + Standard of Care (n = 225)	Esketamine 84 mg* + Standard of Care (n = 226)	All Patients (N = 451)
Age, mean (SD), y	39.6 (13.08)	40.5 (12.92)	40.1 (13.00)
Sex, n (%)
Female	140 (62.2)	134 (59.3)	274 (60.8)
Male	85 (37.8)	92 (40.7)	177 (39.2)
Race, n (%)
White	161 (71.6)	169 (74.8)	330 (73.2)
Asian	30 (13.3)	29 (12.8)	59 (13.1)
Black or African American	15 (6.7)	11 (4.9)	26 (5.8)
Other/not reported	19 (8.4)	17 (7.5)	36 (8.0)
Region, n (%)
North America	65 (28.9)	58 (25.7)	123 (27.3)
Europe	106 (47.1)	117 (51.8)	223 (49.4)
Asia	27 (12.0)	26 (11.5)	53 (11.8)
South America	27 (12.0)	25 (11.1)	52 (11.5)
MADRS total score,† mean (SD)	40.4 (6.04)	40.3 (5.60)	40.4 (5.82)
CGI-SS-r,† n (%)
Normal, not at all suicidal	0	0	0
Questionably suicidal	6 (2.7)	6 (2.7)	12 (2.7)
Mildly suicidal	17 (7.6)	16 (7.1)	33 (7.3)
Moderately suicidal	61 (27.1)	64 (28.4)	125 (27.8)
Markedly suicidal	84 (37.3)	86 (38.2)	170 (37.8)
Severely suicidal	55 (24.4)	46 (20.4)	101 (22.4)
Among the most extremely suicidal patients	2 (0.9)	7 (3.1)	9 (2.0)
Suicide attempt, n (%)
Attempt in the last month	55 (24.4)	68 (30.1)	123 (27.3)
Attempt during lifetime†	140 (62.2)	144 (64.0)	284 (63.1)
Standard-of-care antidepressant,‡ n (%)
Antidepressant monotherapy	108 (48.0)	104 (46.0)	212 (47.0)
Antidepressant plus augmentation therapy§	117 (52.0)	122 (54.0)	239 (53.0)

*Includes patients who had their dose reduced because of tolerability issues.

^†Two hundred twenty-five for the esketamine + standard-of-care group.

^‡As randomized.

^§Augmentation therapy included an agent, such as a second antidepressant, an atypical antipsychotic, or a mood stabilizer.