| VNS + TAU (N = 97) | TAU (N = 59) | P * |
---|---|---|---|
Mean age ± SD (years) | 47.0 ± 10.2 | 47.8 ± 10.6 | 0.65 |
Female, n (%) | 72 (74.2%) | 47 (79.7%) | 0.56 |
White, n (%) | 93 (95.9%) | 56 (94.9%) | 1 |
Mean age ± SD at initial onset of depressive symptoms (years) | 20.0 ± 11.5 | 18.9 ± 9.2 | 0.51 |
Mean age ± SD at initial diagnosis of depression (years) | 26.9 ± 10.6 | 27.9 ± 11.6 | 0.59 |
Lifetime number of diagnosed depressive episode | 20.7 ± 29.2 | 13.7 ± 23.2 | 0.10 |
Psychiatric hospitalizations within the 5 years prior to registry enrollment | 3.6 ± 5.4 | 1.5 ± 2.1 |  < 0.001 |
Lifetime suicide attempts | 2.7 ± 4.8 | 1.5 ± 2.9 | 0.05 |
DSM-IV-TR primary diagnosis, n (%) | |||
 Bipolar I disorder, currently moderately severe major depressive episode | 19 (19.6%) | 18 (30.6%) | 0.17 |
 Bipolar I disorder, currently severe major depressive episode | 46 (47.4%) | 10 (16.9%) |  < 0.001 |
 Bipolar II disorder, currently depressed | 32 (33.0%) | 31 (52.5%) | 0.025 |
Baseline scores, n (%) | |||
 Montgomery–Åsberg Depression Rating Scale | 33.7 ± 7.3 | 29.7 ± 5.9 |  < 0.001 |
 Clinical Global Impression—Severity | 5.2 ± 0.8 | 4.7 ± 0.7 |  < 0.001 |
 Quick Inventory of Depressive Symptomatology-Self Report | 18.4 ± 4.9 | 15.9 ± 5.2 | 0.004 |
 Suicidality-based on MADRS Item 10 | 2.7 ± 1.4 | 2.0 ± 1.2 | 0.003 |