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Table 2 Summary of demographics and anchor variables at Baseline

From: Assessing the meaningful change threshold of Quality of Life in Depression Scale using data from two phase 3 studies of esketamine nasal spray

Parameter

ASPIRE I (n = 224)

ASPIRE II (n = 227)

Age, years

  

Mean (SD)

39.3 (12.91)

40.8 (13.07)

Range

18–64

18–64

Sex, n (%)

  

Women

138 (61.6)

136 (59.9)

Men

86 (38.4)

91 (40.1)

QLDS

  

Mean (SD)

27.24 (6.40)

26.77 (5.64)

Range

0–34

5–34

MADRS score

  

Mean (SD)

41.1 (6.07)

39.7 (5.48)

Range

29–58

29–54

CGI-SS-r, n (%)

  

Normal, not at all suicidal

0

0

Questionably suicidal

8 (3.6)

4 (1.8)

Mildly suicidal

17 (7.6)

16 (7.0)

Moderately suicidal

57 (25.6)

68 (30.0)

Markedly suicidal

80 (35.9)

90 (39.6)

Severely suicidal

56 (25.1)

45 (19.8)

Among the most extremely suicidal patients

5 (2.2)

4 (1.8)

CGI-SR-I, n (%)

  

No imminent suicide risk

5 (2.2)

3 (1.3)

Minimal imminent suicide risk

12 (5.4)

8 (3.5)

Mild imminent suicide risk

17 (7.6)

18 (7.9)

Moderate imminent suicide risk

57 (25.6)

63 (27.8)

Marked imminent suicide risk

75 (33.6)

80 (35.2)

Severely imminent suicide risk

53 (23.8)

49 (21.6)

Extreme imminent suicide risk

4 (1.8)

6 (2.6)

EQ-VAS

  

Mean (SD)

42.0 (24.44)

39.5 (22.62)

Range

0–100

0–95

  1. CGI-SR-I Clinical Global Impression of Imminent Suicide Risk, CGI-SS-r Clinical Global Impression of Severity of Suicidality-Revised, EQ-VAS EuroQol Visual Analog Scale, MADRS Montgomery–Åsberg Depression Rating Scale, QLDS Quality of Life Depression Scale, SD Standard Deviation