Table 6.
Week 28 outcome measures by baseline QIDS-SR16
| Measure | Baseline QIDS-SR16 |
Unadjusted |
Adjusted* |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mild n=81 |
Moderate n=238 |
Severe n=260 |
Very severe n=67 |
Moderate vs. Mild |
Severe vs. Mild |
Very severe vs. mild |
p-value | Moderate vs. Mild |
Severe vs. Mild |
Very severe vs. mild |
p-value | |
| % | % | % | % | OR | OR | OR | OR | OR | OR | |||
| Exited acute phase | 35.8 | 36.1 | 37.7 | 37.3 | 1.043 | 1.092 | 1.051 | 0.9899 | 1.093 | 0.960 | 0.654 | 0.6185 |
| Severe/intolerable | 1.3 | 0.9 | 4.0 | 1.6 | ||||||||
| At least 1 SAE† | 6.2 | 5.9 | 6.5 | 10.4 | 0.945 | 0.936 | 1.358 | 0.9144 | 1.053 | 0.987 | 0.909 | 0.9972 |
| At least 1 psychiatric SAE† | 1.2 | 1.7 | 2.7 | 4.5 | ||||||||
| Last 2 consecutive QIDS-SR16 <6|8 | 63.0 | 47.1 | 40.0 | 34.3 | 0.544 | 0.386 | 0.369 | 0.0033 | 0.624 | 0.591 | 0.839 | 0.2882 |
| Percent QIDS-SR16 reduction >50% | 59.3 | 58.1 | 54.9 | 72.7 | 1.037 | 0.828 | 1.991 | 0.0670 | 1.210 | 1.353 | 5.548 | 0.0020a |
| Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | β | β | β | β | β | β | |||
| Maximum SAFTEE N worsening | 10.9 (8.8) | 9.9 (6.1) | 10.2 (6.4) | 10.1 (6.8) | 0.978 | 0.984 | 0.954 | 0.9844 | 0.968 | 0.955 | 0.890 | 0.9040 |
| Last SAFTEE N worsening | 5.5 (6.0) | 4.6 (5.1) | 5.1 (5.3) | 4.7 (5.1) | −0.180 | −0.154 | −0.126 | 0.6436 | −0.132 | −0.147 | −0.234 | 0.8006 |
| Last QIDS-SR16 | 4.6 (4.3) | 6.8 (4.5) | 9.1 (6.2) | 9.0 (6.2) | 1.519 | 2.011 | 1.892 | <.0001 | 1.394 | 1.605 | 1.224 | 0.0013b |
| Percent QIDS-SR16 change | −43 (46.6) | −49 (33.5) | −50 (33.6) | −60 (27.5) | −6.871 | −6.510 | −18.28 | 0.0282 | −8.412 | −12.73 | −32.40 | 0.0003c |
| IDS-C30 anxiety subscale | 1.9 (1.9) | 2.3 (2.1) | 2.8 (2.3) | 2.8 (2.0) | 0.177 | 0.382 | 0.367 | 0.0090 | 0.097 | 0.111 | −0.118 | 0.3213 |
| Last QOLI | 1.61 (2.11) | 0.79 (2.18) | −0.10 (2.39) | 0.10 (2.77) | −0.853 | −1.769 | −1.604 | <.0001 | −0.471 | −0.942 | −0.271 | 0.0234 |
Note: models assume either OR=1 or β=1 for reference category of the analysis variable.
QIDS-SR16 categories: mild = 0–10, moderate = 11–15, severe = 16–20, very severe = 21–27.
adjusted for treatment, age, sex, PDSQ, bulimia, OCD, PTSD, atypical and melancholic features, insomnia, CAST irritability and mania, CHRT, CPFQ, and WSAS.
models are unestimable.
an extremely non-normal distribution required binning.
Post-hoc tests indicate the following pairwise differences after correcting for multiple comparison:
Very severe vs. Moderate, Very severe vs. severe.
Moderate vs. Mild.
Very severe vs. Moderate, Very severe vs. Severe.
Abbreviations:; QIDS-SR16, 16 item quick inventory of depressive symptomatology – self-rated; QOLI, Quality of life inventory; SAE, Serious adverse event; SAFTEE, Systematic assessment for treatment emergent events; WSAS, Work and social adjustment scale.