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Table 1 Demographics and Baseline Characteristics

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)

Age (years)

 Mean (SD)

45.9 (9.97)

42.5 (8.36)

41.9 (10.26)

43.3 (11.40)

43.4 (10.35)

Sex, n (%)

 Male

18 (43.9%)

24 (60.0%)

23 (56.1%)

41 (51.3%)

106 (52.5%)

 Female

23 (56.1%)

16 (40.0%)

18 (43.9%)

39 (48.8%)

96 (47.5%)

Baseline BMI (kg/m2)

 Mean (SD)

25.81 (4.733)

24.37 (5.388)

23.86 (3.949)

25.01 (4.729)

24.81 (4.735)

Hypertension statusa, n (%)

 Yes

5 (12.2%)

11 (27.5%)

9 (22.0%)

10 (12.5%)

35 (17.3%)

 No

36 (87.8%)

29 (72.5%)

32 (78.0%)

70 (87.5%)

167 (82.7%)

Oral antidepressant, n (%)

 Duloxetine

1 (2.4%)

4 (10.0%)

4 (9.8%)

11 (13.8%)

20 (9.9%)

 Venlafaxine XR

9 (22.0%)

7 (17.5%)

4 (9.8%)

10 (12.5%)

30 (14.9%)

 Escitalopram

18 (43.9%)

11 (27.5%)

17 (41.5%)

25 (31.3%)

71 (35.1%)

 Sertraline

8 (19.5%)

11 (27.5%)

10 (24.4%)

23 (28.8%)

52 (25.7%)

 Paroxetine CR

2 (4.9%)

6 (15.0%)

1 (2.4%)

5 (6.3%)

14 (6.9%)

 Mirtazapine

3 (7.3%)

1 (2.5%)

5 (12.2%)

6 (7.5%)

15 (7.4%)

Age when diagnosed with MDD (years)

 Mean (SD)

37.9 (10.80)

33.5 (9.51)

32.8 (9.76)

34.4 (11.18)

34.6 (10.58)

  1. aHypertension status = Yes, if SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg at least one time point before DB Induction Phase. Hypertension status = No, if SBP < 140 mmHg and DBP < 90 mmHg at all time points before the DB Induction Phase
  2. Abbreviations: BMI body mass index, CR controlled-release, DB double-blind, DBP diastolic blood pressure, Esk esketamine, MDD major depressive disorder, N number of patients, n subset of patients, SBP systolic blood pressure, SD standard deviation, XR extended-release