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Table 2 Primary outcomes, secondary outcomes and safety

From: Agomelatine as adjunctive therapy with SSRIs or SNRIs for major depressive disorder: a multicentre, double-blind, randomized, placebo-controlled trial

Variables

Agomelatine + SSRI or SNRI

Placebo + SSRI or SNRI

Comparison

No

Mean (SD)

No

Mean (SD)

Adjusted difference in means (95% CI)

P value

Effect size (Cohen’s d)

Primary outcome

 HAMD-17 at week 8

60

7.2 (5.2)

63

7.4 (6.3)

 − 0.12 (− 3.94 to 3.70)

0.90

 − 0.022

Secondary outcomes

 Remission

60

30 (50.0%)

63

33 (52.3%)

0.88 (0.42–1.85) a

0.74

41 b

 Response

60

36 (60.0%)

63

41 (65.2%)

0.85 (0.40–1.80) a

0.68

20b

 HAMD-17 at week 2

60

11.7 (4.7)

63

12.4 (6.8)

 − 0.20 (− 4.12 to 3.73)

0.83

 − 0.038

 HAMD-17 at week 4

60

8.5 (5.2)

63

9.1 (5.6)

 − 0.27 (− 4.31 to 3.78)

0.76

 − 0.057

 PHQ-9

60

7.3 (4.8)

63

7.0 (6.2)

0.39 (− 2.79 to 3.57)

0.67

0.077

 HAMA

60

7.0 (6.0)

63

6.8 (6.9)

0.36 (− 3.16 to 3.88)

0.72

0.066

 GAD-7

60

4.8 (4.1)

63

3.2 (3.7)

1.32 (− 0.39 to 3.03)

0.06

0.351

 AIS

60

4.7 (3.8)

63

4.8 (5.2)

 − 0.02 (− 2.48 to 2.44)

0.98

 − 0.004

 CGI severity

60

2.5 (1.4)

63

2.3 (1.5)

0.16 (− 0.95 to 1.28)

0.46

0.134

 SHAPS

60

29.2 (8.3)

63

29.1 (8.5)

0.87 (− 4.66 to 6.40)

0.51

0.122

 SDS

56

2.6 (2.1)

56

2.3 (2.3)

0.36 (− 0.94 to 1.65)

0.36

0.176

Executive function

       

 DSB

51

6.9 (2.2)

48

7.2 (1.8)

 − 0.09 (− 0.81 to 0.63)

0.76

 − 0.063

 DSST

45

68.9 (12.3)

43

69.4 (14.2)

 − 2.47 (− 8.28 to 3.33)

0.25

 − 0.251

 Stroop Color-Word

49

52.8 (17.5)

48

55.9 (18.8)

 − 1.61 (− 14.62 to 11.39)

0.59

 − 0.113

 TMT-B

42

45.8 (17.6)

45

47.7 (21.6)

 − 2.43 (− 21.28 to 16.41)

0.52

 − 0.142

Attention

       

 DSF

50

9.0 (1.6)

48

9.3 (1.8)

0.03 (− 0.52 to 0.57)

0.91

0.024

 Stroop-Word

49

94.1 (16.6)

48

96.8 (17.1)

 − 2.88 (− 11.38 to 5.63)

0.39

 − 0.176

Processing speed

       

 TMT-A

42

21.6 (6.6)

45

21.3 (7.3)

1.59 (− 2.16 to 5.34)

0.26

0.253

 Stroop-Color

49

80.8 (18.9)

48

85.5 (20.0)

 − 5.36 (− 15.95 to 5.23)

0.13

 − 0.332

Memory

       

 HVLT-R

48

25.7 (6.4)

50

25.9 (5.3)

1.39 (− 2.4 to 5.19)

0.68

 − 0.086

 HVLT-delayed recall trial

48

9.6 (3.8)

50

8.8 (2.4)

0.77 (− 0.70 to 2.25)

0.20

0.264

SERS

60

0.5 (1.2)

63

0.4 (1.2)

 − 0.01 (− 0.54 to 0.52)

0.95

 − 0.012

  1. a, estimated OR and the 95%CI were calculated in logistic LMM; b, effect sizes were calculated as NNT. HAMD-17 Hamilton Depression Rating Scale 17-item version, HAMA Hamilton Anxiety Rating Scale, PHQ-9 9-item Patient Health Questionnaire-9, GAD-7 7-tiem Generalized Anxiety Disorder Scale, CGI-S Clinical Global Impression Severity Scale, SHAPS Snaith Hamilton Anhedonia Pleasure Scale, AIS Athens Insomnia Scale, SDS Sheehan Disability Scale, EQ-5D-3L EuroQol Five Dimensions Questionnaire Three-Level, DSB Digit Span Backward Test, DSST Digital Symbol Substitution test, TMT-A Trial–Making Part A task, TMT-B Trial–Making Part B test, DSF Digit Span Forward test, HVLT Hopkins Verbal Learning Test, SERS Side Effects Rating Scale
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BMC Medicine

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