| Baseline demographics | By propensity score quintile
|
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 1
|
2
|
3
|
4
|
5
|
||||||
| TAU (N= 147) |
VNS + TAU (N = 143) |
TAU (N = 86) |
VNS + TAU (N = 205) |
TAU (N = 76) |
VNS+ TAU (N = 215) |
TAU (N = 61) |
VNS + TAU (N = 230) |
TAU (N = 53) |
VNS + TAU (N = 238) |
|
| Age, years ± SD | 49.6 ± 10.8 | 47.5 ± 10.5 | 49.3 ± 11.7 | 45.8 ± 10.3 | 49.7 ± 10.3 | 49.9 ± 95 | 47.1 ± 10.8 | 48.2 ± 10.5 | 45.9 ± 10.8 | 47.4 ± 9.9 |
| Female, % | 80.3% | 81.1% | 73.3% | 65.4% | 65.8% | 63.3% | 57.4% | 62.2% | 52.8% | 64.3% |
| Caucasian, % | 76.9% | 86.7% | 100.0% | 96.6% | 97.4 | 99.5% | 95.1% | 99.1% | 98.1% | 97.5% |
| Primary diagnosis of current MDE | ||||||||||
| MDD, % | 88.4% | 83.2% | 69.8% | 77.6% | 73.7% | 79.5% | 73.8% | 73.0% | 88.7% | 77.7% |
| Bipolar disorder, % | 11.6% | 16.8% | 30.2% | 22.4% | 26.3% | 20.5% | 26.2% | 27.0% | 11.3% | 22.3% |
| Length of illness, years ± SD | 31.2 ± 13.9 | 30.7 ± 12.3 | 28.8 ± 14.0 | 24.9 ± 11.4 | 26.2 ± 14.4 | 28.5 ± 13.0 | 24.3 ± 11.1 | 26.3 ± 13.0 | 22.1 ± 12.0 | 21.1 ± 11.8 |
| Length of current episode, years ± SD | 7.5 ± 9.9 | 5.5 ± 6.8 | 67 ± 9.1 | 7.2 ± 9.0 | 7.5 ± 9.4 | 6.5 ± 8.6 | 7.6 ± 10.8 | 6.6 ± 8.9 | 9.6 ± 12.7 | 8.2 ± 9.7 |
| Prior ECT, % | 6.1% | 7.7% | 20.9% | 11.2% | 51.3% | 54.0% | 82.0% | 89.1% | 98.1% | 93.7% |
| Prior drug treatment classes, n ± SD | 4.2 ± 1.S | 4.7 ± 1.5 | 5.6 ± 1.5 | 5.8 ± 1.5 | 63 ± 1.7 | 6.5 ± 1.8 | 7.0 ± 1.9 | 7.3 ± 1.5 | 9.0 ± 1.5 | 9.3 ± 1.8 |
| Lifetime depression related hospitalizations, mean ± SD | 0.9 ± 1.8 | 1.4 ±2.3 | 1.2 ± 2.0 | 2.6 ± 8.0 | 1.9 ± 2.7 | 2.9 ± 4.7 | 2.5 ± 3.7 | 4.4 ± 6.4 | 5.3 ± 9.5 | 4.9 ± 5.8 |
| Lifetime suicide attempts, mean ± SD | 1.1 ±2.3 | 0.9 ± 1.7 | 1.1 ± 2.3 | 1.1 ±2.9 | 1.1 ± 1.6 | 1.2 ± 2.7 | 1.5 ±3.5 | 1.4 ±2.6 | 1.2± 1.7 | 1.9 ± 4.6 |
| Baseline MADRS score ± SD | 28.8 ± 66 | 32.0 ± 6.7 | 28.3 ± 8.3 | 32.3 ±6.1 | 29.9 ± 6.6 | 33.4 ±7.1 | 30.5 ± 7.2 | 33.6 ± 6.0 | 30.2 ± 6.1 | 33.2 ±6.1 |
| Baseline CGI severity subscale score ± SD | 4.5 ± 0.6 | 5.2 ± 0.8 | 4.5 ± 0.7 | 5.2 ± 0.7 | 4.7 ± 0.7 | 5.2 ± 0.7 | 4.7 ± 0.7 | 5.2 ± 0.8 | 5.1 ±0.7 | 5.3 ± 0.8 |
| Patient-years of exposurea | 278.3 | 261.1 | 155.3 | 401.7 | 161.5 | 442.1 | 137.3 | 447.9 | 134.8 | 494.5 |
Notes: TAU cohort includes all enrolled patients and VNS + TAU cohort includes all patients implanted with a VNS Therapy® (Cyberonics, Inc, Houston, TX, USA) device. Number of hospitalizations and number of lifetime suicide attempts were not collected in Study D-01.
a
Patient-years of exposure to treatment for the TAU cohort is from baseline to last visit and for the VNS + TAU cohort is implant to last visit.
Abbreviations: CGI, Clinical Global Impressions-Severity scale; ECT, electroconvulsive therapy; MADRS, Montgomery-Åsberg Depression Rating Scale; MDD, major depressive disorder; MDE, major depressive episode; N, number; SD, standard deviation; TAU, treatment as usual; VNS, vagus nerve stimulation.