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|
Outcome measure
|
Mean baseline score
|
Mean change (SE)
|
|---|
| | |
Week 6
|
Week 28
|
Week 52
|
|---|
|
CGI-Severity
|
4.51
|
-2.08 (0.11)**
|
-2.93 (0.12)**
|
-3.15 (0.12)**
|
|
PGI-Improvement
|
N/A
|
2.33 (0.14)**
|
1.83 (0.16)**
|
1.84 (0.16)**
|
|
HAMD
17
Total Score
|
21.8
|
-13.0 (0.7)**
|
-17.4 (0.8)**
|
-17.5 (0.8)**
|
|
Anxiety subscale
|
6.70
|
-3.46 (0.30)**
|
-4.89 (0.33)**
|
-4.90 (0.34)**
|
|
Core subscale
|
8.83
|
-5.65 (0.33)**
|
-7.50 (0.36)**
|
-7.61 (0.38)**
|
|
Maier subscale
|
10.7
|
-6.64 (0.38)**
|
-8.90 (0.42)**
|
-9.06 (0.44)**
|
|
Retardation subscale
|
7.84
|
-4.49 (0.27)**
|
-6.58 (0.30)**
|
-6.49 (0.31)**
|
|
Sleep subscale
|
3.68
|
-2.34 (0.21)**
|
-2.84 (0.23)**
|
-2.83 (0.24)**
|
|
HAMD17 Item 1
|
2.64
|
-1.73 (0.11)**
|
-2.30 (0.13)**
|
-2.30 (0.13)**
|
|
HAMD17 Item 3
|
0.74
|
-0.58 (0.06)**
|
-0.59 (0.06)**
|
-0.61 (0.06)**
|
|
BDI-II Total Score
|
29.5
|
-15.8 (1.0)**
|
-22.3 (1.1)**
|
-22.0 (1.1)**
|
|
Sheehan Disability Scale
| | | | |
|
Work item
|
6.91
|
-3.01 (0.32)**
|
-4.60 (0.37)**
|
-4.27 (0.39)**
|
|
Family item
|
6.82
|
-3.63 (0.32)**
|
-4.88 (0.35)**
|
-4.95 (0.37)**
|
|
Social item
|
7.27
|
-3.45 (0.34)**
|
-4.57 (0.38)**
|
-4.85 (0.40)**
|
- ** p < .001 from t-test for mean change
- CGI-Severity = Clinical Global Impression of Severity; PGI-Improvement = Patient Global Impression of Improvement; HAMD17 = 17-item Hamilton Rating Scale for Depression; BDI-II = Beck Depression Inventory-II