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Table 1 Summary of included trials

From: The safety and efficacy of vortioxetine for acute treatment of major depressive disorder: a systematic review and meta-analysis

Author NCT identifier FDA identifier

Country

N

Arms

Mean age

Baseline MADRS score

% non-white

% female

Follow-up

Study quality

Alvarez et al NCT00839423 11492Aa

Non-US

429

V 5 V 10 mg VLFX 225 mg

43.3

34.0

8.0

62.7

6 weeks

Good

Mahableshwarker et al NCT00672620 304b

US

611

V 2.5 mg V 5 mg DLX 60 mg placebo

42.7

29.8

26.0

63.5

8 weeks

Fair

Baldwin et al NCT00635219 11984Ab

Non-US

776

V 2.5 mg V 5 mg V 10 mg DLX 60 mg placebo

44.9

31.9

21

68.1

8 weeks

Fair

Jain et al NCT00672958 303b

US

600

V 5 mg placebo

42.4

34.1

29.2

58.3

6 weeks

Fair

Katona et al NCT00811252 12541Aa

US and Non-US

453

V 5 mg DLX 60 mg placebo

70.6

30.5

5.3

65.7

8 weeks

Good

Henigsberg et alNCT00735709 305a

Non-US

560

V 1 mg V 5 mg V 10 mg placebo

46.4

30.8

13.8

62.7

8 weeks

Poor

Boulenger et al NCT01140906 13267Aa

Non-US

608

V 15 mg V 20 mg DLX 60 mg placebo

46.7

31.4

1.8

65.9

8 weeks

Fair

McIntyre et al NCT01422213 FOCUS

US and Non-US

598

V 10 mg V 20 mg placebo

45.7

31.5

5.5

66.2

8 weeks

Good

Unpublished NCT01153009 315a

US

614

V 15 mg V 20 mg DLX 60 mg placebo

42.9

32.1

23.4

73.8

8 weeks

Fairc

Unpublished NCT01163266 316a

US

462

V 10 mg V 20 mg placebo

42.8

32.2

30.1

72.5

8 weeks

Fairc

Unpublished NCT01179516 317b

US

434

V 10 mg V 15 mg placebo

45.1

33.7

25.8

70.1

8 weeks

Fairc

  1. V = vortioxetine; VLFX = venlafaxine XR; DLX = duloxetine; NR = not reported; NCT = national clinical trial number. aConsidered positive by FDA; bconsidered failed or negative by FDA; conly evaluable trial characteristics assessed.