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Table 2 Main outcome table. Baseline Montgomery Åsberg Depression Rating Scale (MADRS) scores and change in the depressive symptoms over 52 weeks for patients in the intention-to-treat and per-protocol analysis. Values are means unless stated otherwise. Estimated mean differences and 95% Confidence Intervals (CIs) are presented.

From: Clinical effectiveness of usual care with or without antidepressant medication for primary care patients with minor or mild-major depression: a randomized equivalence trial

 

Intention-to-treat MADRS (n = 181)

 

Usual care + paroxetine (n = 85)

Usual care (n = 96)

Mean difference*

SD

95% CI

Baseline score

23.7

24.1

   

6 weeks – baseline†

-7.6

-6.0

-1.6

20.2

-4.7; 1.4‡

13 weeks – baseline †

-10.2

-8.7

-1.5

22.5

-5.1; 1.9

26 weeks – baseline †

-13.0

-10.0

-3.0

21.3

-6.4; 0.3

52 weeks – baseline †

-14.7

-12.6

-2.1

24.1

-6.1; 1.9

 

Per-protocol MADRS (n = 133)

 

Usual care + paroxetine (n = 55)

Usual care (n = 78)

Mean difference*

SD

95% CI

Baseline score

25.1

24.1

   

6 weeks-baseline†

-7.8

-6.7

-1.1

20.0

-4.5; 2.4‡

13 weeks-baseline†

-12.1

-9.0

-3.1

20.7

-6.8; 0.5

26 weeks-baseline†

-13.9

-9.3

-4.6

20.6

-8.4; -0.9§

52 weeks-baseline†

-17.6

-12.6

-5.0

21.2

-9.1; -1.0§

  1. *A negative mean difference is a difference in favor of usual care + paroxetine.
  2. †A negative score means a decrease in the severity of symptoms.
  3. ‡The 95% CI of the difference in symptom change lies entirely between the equivalence margins of -5 and +5 points, indicating equivalence of usual care + paroxetine and usual care.
  4. §The 95% CI of the difference in symptom change lies entirely to the left of zero, indicating statistical significant differences in favor of usual care + paroxetine.