Week 12 and 28 Outcome Measures by Number of General Medical Conditions
| No. of General Medical Conditions | Unadjusted | Adjusteda | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Measure | 0 (n = 328) | 1 (n = 158) | 2 (n = 98) | ≥3 (n = 79) | 0 vs 1 | 0 vs 2 | 0 vs ≥3 | P Value | 0 vs 1 | 0 vs 2 | 0 vs ≥3 | P Value |
| No. (%) | Odds Ratio | Odds Ratio | ||||||||||
| Week 12 | ||||||||||||
| Exited acute phase | 90 (27.4) | 47 (29.7) | 25 (25.5) | 19 (24.1) | 1.12 | 1.01 | 0.85 | .88 | 1.31 | 1.12 | 0.94 | .69 |
| Remissionb | 135 (41.2) | 60 (38.0) | 37 (37.8) | 24 (30.4) | 0.90 | 0.95 | 0.58 | .29 | 0.89 | 0.98 | 0.67 | .62 |
| Last QIDS-SR16 <6 | 129 (39.6) | 55 (34.8) | 35 (36.5) | 23 (29.1) | 0.84 | 1.08 | 0.68 | .44 | 0.86 | 1.15 | 0.82 | .72 |
| Responsec | 172 (54.8) | 77 (50.0) | 51 (54.3) | 34 (43.0) | 0.80 | 1.03 | 0.64 | .28 | 0.89 | 1.28 | 0.81 | .55 |
| Last WSASd | – | – | – | – | 1.26 | 1.40 | 2.35 | .005 | 1.34 | 1.40 | 2.17e | .04 |
| Maximum FIBSER Frequency | – | – | – | – | 1.05 | 1.04 | 0.81 | .79 | 1.29 | 1.21 | 1.09 | .65 |
| Maximum FIBSER Intensity | – | – | – | – | 1.04 | 0.84 | 0.70 | .43 | 1.34 | 0.93 | 0.97 | .44 |
| Maximum FIBSER Burden | – | – | – | – | 1.12 | 0.83 | 0.89 | .69 | 1.25 | 0.83 | 0.95 | .49 |
| At least 1 SAE | 12 (3.7) | 7 (4.4) | 5 (5.1) | 3 (3.8) | 0.61 | 1.45 | 0.36 | .53 | 0.53 | 1.29 | 0.22 | .39 |
| Week 28 | ||||||||||||
| Exited continuation phase | 123 (37.5) | 60 (38.0) | 37 (37.8) | 23 (29.1) | 0.92 | 0.99 | 0.68 | .58 | 1.11 | 1.18 | 0.74 | .58 |
| Remissionb | 160 (48.8) | 69 (43.7) | 38 (38.8) | 31 (39.2) | 0.87 | 0.71 | 0.67 | .35 | 0.78 | 0.72 | 0.76 | .58 |
| Last QIDS-SR16 <6 | 156 (48.4) | 69 (43.7) | 35 (36.1) | 32 (40.5) | 0.82 | 0.69 | 0.70 | .35 | 0.78 | 0.71 | 0.80 | .57 |
| Responsec | 188 (60.6) | 93 (60.4) | 51 (53.7) | 42 (53.2) | 0.92 | 0.89 | 0.70 | .62 | 0.90 | 1.01 | 0.78 | .84 |
| Last WSASd | – | – | – | – | 1.15 | 1.31 | 1.70 | .14 | 1.20 | 1.30 | 1.49 | .48 |
| Maximum FIBSER Frequency | – | – | – | – | 1.06 | 1.09 | 0.86 | .85 | 1.39 | 1.36 | 1.27 | .40 |
| Maximum FIBSER Intensity | – | – | – | – | 1.02 | 0.89 | 0.80 | .77 | 1.31 | 0.99 | 1.11 | .61 |
| Maximum FIBSER Burden | – | – | – | – | 1.13 | 0.87 | 1.09 | .79 | 1.25 | 0.86 | 1.17 | .54 |
| At least 1 SAE | 20 (6.1) | 9 (5.7) | 11 (11.2) | 6 (7.6) | 0.56 | 1.88 | 0.80 | .17 | 0.76 | 2.32 | 0.98 | .25 |
| Mean (SD) | β Coefficient | β Coefficient | ||||||||||
| Week 12 | ||||||||||||
| Last QIDS-SR16 | 7.8 (5.3) | 8.1 (5.3) | 8.5 (6.1) | 9.1 (5.0) | 0.425 | 0.390 | 1.230 | .37 | 0.477 | 0.190 | 0.835 | .71 |
| % QIDS-SR16 change | −48 (34.8) | −47 (30.2) | −44 (36.7) | −39 (35.4) | 1.561 | 3.967 | 9.238 | .21 | −0.012 | −0.626 | 3.505 | .88 |
| Last SAFTEE-SI N worse | 5.1 (5.3) | 4.7 (4.5) | 5.7 (5.1) | 5.7 (5.3) | −0.017 | 0.017 | 0.179 | .28 | 0.034 | 0.154 | 0.237 | .34 |
| Week 28 | ||||||||||||
| Last QIDS-SR16 | 7.3 (5.5) | 7.3 (5.3) | 8.4 (6.2) | 8.3 (5.4) | 1.043 | 1.103 | 1.234 | .31 | 1.085 | 1.107 | 1.179 | .58 |
| % QIDS-SR16 change | −52 (35.4) | −52 (30.6) | −45 (37.0) | −44 (38.8) | −0.595 | 5.387 | 8.716 | .17 | −0.315 | 2.779 | 4.552 | .77 |
| Maximum SAFTEE-SI N worse | 9.9 (6.9) | 9.6 (5.8) | 10.6 (7.0) | 11.3 (6.6) | 1.037 | 1.085 | 1.183 | .32 | 1.011 | 1.066 | 1.104 | .81 |
| Last SAFTEE-SI N worse | 4.7 (5.3) | 4.5 (4.7) | 6.0 (5.7) | 5.4 (5.6) | 0.035 | 0.329 | 0.211 | .07 | 0.056 | 0.246 | 0.129 | .40 |
FIBSER = Frequency, Intensity and Burden of Side Effects Rating; QIDS-SR16 = 16-item Quick Inventory of Depressive Symptomatology–Self-Report; SAE = serious adverse event; SAFTEE-SI = Systematic Assessment for Treatment Emergent Events–Systematic Inquiry; WSAS = Work and Social Adjustment Scale.
Notes: WSAS scores range from 0 to 40, with higher scores indicating greater levels of impairment. SCQ scores range from 0 to 45, with higher scores indicating greater number of disorders and greater levels of impairment. QIDS-SR16 scores range from 0 to 27, with higher scores indicating greater levels of depression. FIBSER scores range from 0 to 6 for each of the indexes.
↵a Adjusted for treatment, age, education, employment, age at first episode, body mass index, and systolic blood pressure (see Supplemental Table 1, available at http://www.annfammed.org/content/10/1/23/suppl/DC1).
↵b Patients were classified as being in remission if their last 2 QIDS-SR16 scores were less than 6.
↵c Patients were classified as having a response if they had a decrease in QIDS-SR16 score of at least 50% from baseline.
↵d An extremely nonnormal distribution required binning.
↵e Significant after Bonferroni correction (P <.0083).