Table 5.
Week 12 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 | 23.5 | 25.6 | 30.0 | 29.9 | 1.156 | 1.346 | 1.359 | 0.7472 | 1.250 | 1.283 | 1.033 | 0.8344 |
| At least 1 SAE† | 3.7 | 2.9 | 4.2 | 6.0 | ||||||||
| At least 1 psychiatric SAE† | 0.8 | 1.5 | 1.5 | |||||||||
| Last 2 consecutive QIDS-SR16 <6|8 |
61.7 | 39.9 | 32.3 | 28.4 | 0.439 | 0.299 | 0.287 | 0.0001 | 0.599 | 0.617 | 0.866 | 0.2653 |
| Percent QIDS-SR16 reduction >50% |
48.8 | 49.8 | 53.3 | 58.2 | 1.095 | 1.181 | 1.725 | 0.4308 | 1.370 | 1.874 | 4.236 | 0.0285 |
| 31–40 | 1.3 | 10.4 | 19.0 | 26.6 | ||||||||
| Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | β | β | β | β | β | β | |||
| Maximum SAFTEE N worsening | 9.7 (8.0) | 9.3 (5.7) | 9.8 (6.2) | 9.5 (6.2) | 1.039 | 1.055 | 1.017 | 0.9223 | 1.011 | 0.994 | 0.917 | 0.8430 |
| Last SAFTEE N worsening | 5.1 (5.4) | 5.0(4.9) | 5.5(5.3) | 4.7(4.7) | −0.042 | 0.017 | −0.031 | 0.9377 | −0.014 | 0.012 | −0.200 | 0.6114 |
| Last QIDS-SR16 | 5.2 (4.1) | 7.3 (4.3) | 9.5 (5.9) | 10.0 (6.5) | 1.890 | 4.181 | 4.206 | <.0001 | 0.735 | 1.834 | 0.388 | 0.0364 |
| Percent QIDS-SR16 change | −35 (47.2) | −46(31.5) | −47 (32.5) | −55 (28.7) | −11.20 | −12.44 | −22.48 | 0.0019 | −14.79 | −20.05 | −36.39 | <.0001a |
| IDS-C30 anxiety subscale | 1.8 (1.9) | 2.4 (2.0) | 2.9 (2.3) | 3.0 (2.1) | 0.273 | 0.445 | 0.451 | 0.0013 | 0.129 | 0.097 | −36.39 | 0.1922 |
| Last QOLI | 1.42 (2.17) | 0.58 (2.11) | −0.51 (2.20) | −0.26 (2.80) | −0.918 | −1.969 | −1.845 | <.0001 | −0.410 | −0.906 | −0.222 | 0.0174 |
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:
Severe vs. None, 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.