Table 2 Efficacy outcomes (mITT population)

HAMD score

Baseline; mean ± SD

13.00 ± 4.24

13.48 ± 3.97

Week 12; mean ± SD

8.39 ± 4.02

10.08 ± 4.38

Treatment effect; LS mean ± SE

(95%CI)

− 4.72 ± 0.38

(− 5.47, − 3.97)

− 3.29 ± 0.39

(− 4.05, − 2.53)

0.009^a*

UPDRS-III score

Baseline; mean ± SD

23.98 ± 11.86

23.93 ± 11.14

Week 12; mean ± SD

22.65 ± 11.55

23.44 ± 12.26

Treatment effect; LS mean ± SE

(95%CI)

− 1.32 ± 0.70

(− 2.72, 0.74)

− 0.49 ± 0.72

(− 1.91, 0.92)

0.413^a

PDQ-8 score

Baseline; mean ± SD

8.70 ± 3.77

8.93 ± 4.26

Week 12; mean ± SD

6.93 ± 3.50

7.34 ± 3.86

Treatment effect; LS mean ± SE

(95%CI)

− 1.80 ± 0.28

(− 2.37, − 1.25)

− 1.54 ± 0.29

(− 2.11, − 0.98)

0.514^a

GDS-15 score

Baseline; mean ± SD

6.36 ± 3.00

6.99 ± 3.08

Week 12; mean ± SD

5.10 ± 3.00

5.83 ± 3.11

Treatment effect; LS mean ± SE (95%CI)

− 1.37 ± 0.25

(− 1.86, − 0.88)

− 1.05 ± 0.25

(− 1.55, − 0.55)

0.373^a

PDSS-2 score

Baseline; mean ± SD

20.49 ± 13.81

21.70 ± 15.44

Week 12; mean ± SD

13.92 ± 12.28

18.43 ± 14.95

Treatment effect; LS mean ± SE (95%CI)

− 6.70 ± 0.79

(− 8.25, − 5.15)

− 3.15 ± 0.80

(− 4.72, − 1.57)

0.002^a*

Clinical remission; n (%)

41 (46.1%)

27 (31.0%)

0.041^b*

Responder; n (%)

31 (34.8%)

16 (18.4%)

0.014^b*