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Table 2 Baseline Psychiatric History

From: Efficacy and safety of fixed doses of intranasal Esketamine as an add-on therapy to Oral antidepressants in Japanese patients with treatment-resistant depression: a phase 2b randomized clinical study

Category

Esk28 (N = 41)

Esk56 (N = 40)

Esk84 (N = 41)

Placebo (N = 80)

Total (N = 202)

Baseline MADRS total score

 Mean (SD)

38.4 (6.07)

37.9 (5.41)

35.9 (5.28)

37.7 (5.65)

37.5 (5.64)

Baseline CGI-S score

 Mean (SD)

4.7 (0.69)

4.7 (0.73)

4.7 (0.75)

4.7 (0.79)

4.7 (0.75)

Baseline CGI-Sa, n (%)

 Moderately ill

18 (43.9%)

19 (47.5%)

19 (46.3%)

36 (45.0%)

92 (45.5%)

 Markedly ill

18 (43.9%)

15 (37.5%)

15 (36.6%)

31 (38.8%)

79 (39.1%)

 Severely ill

5 (12.2%)

6 (15.0%)

7 (17.1%)

11 (13.8%)

29 (14.4%)

 extremely ill patients

0

0

0

2 (2.5%)

2 (1.0%)

Baseline C-SSRSb, n (%)

 No event

33 (80.5%)

33 (82.5%)

36 (87.8%)

60 (75.0%)

162 (80.2%)

 Suicidal ideation

8 (19.5%)

7 (17.5%)

5 (12.2%)

20 (25.0%)

40 (19.8%)

Duration of current episode at screening (weeks)

 Mean (SD)

73.9 (115.38)

55.5 (46.99)

65.0 (98.93)

61.4 (118.89)

63.5 (103.04)

Number of previous treatments in current episodec, n (%)

 2

19 (46.3%)

22 (55.0%)

21 (51.2%)

42 (52.5%)

104 (51.5%)

 3 or more

22 (53.7%)

18 (45.0%)

20 (48.8%)

38 (47.5%)

98 (48.5%)

Number of episodes including current episode, n (%)

 1

1 (2.4%)

0

1 (2.4%)

1 (1.3%)

3 (1.5%)

 2–3

25 (61.0%)

30 (75.0%)

22 (53.7%)

56 (70.0%)

133 (65.8%)

  > 3

15 (36.6%)

10 (25.0%)

18 (43.9%)

23 (28.8%)

66 (32.7%)

Had been considered to be eligible for electroconvulsive therapy, n (%)

 Yes

10 (24.4%)

9 (22.5%)

11 (26.8%)

15 (18.8%)

45 (22.3%)

 No

31 (75.6%)

28 (70.0%)

25 (61.0%)

62 (77.5%)

146 (72.3%)

 Unknown

0

3 (7.5%)

5 (12.2%)

3 (3.8%)

11 (5.4%)

  1. aThe CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a patient was assessed on severity of mental illness at the time of rating according to: 0 = not assessed; 1 = normal (not at all ill); 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients
  2. bC-SSRS category: No event = 0; Suicidal ideation = 1, 2, 3, 4, 5; Suicidal behavior = 6, 7, 8, 9, 10
  3. cNumber of AD medications taken for at least 6 weeks during the current episode as obtained from MGH-ATRQ and plus 1 for the new oral AD taken at screening phase
  4. Abbreviations: AD antidepressant, CGI-S Clinical Global Impression-Severity, C-SSRS Columbia-Suicide Severity Rating Scale, Esk esketamine, MADRS Montgomery-Asberg Depression Rating Scale, MGH-ATRQ Massachusetts General Hospital–Antidepressant Treatment Response Questionnaire, N number of patients, SD standard deviation