Table 2.
Mood and quality-of-life outcome measures
| Baseline | Week 2 | Week 4 | Condition | Time | Time × Condition | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mood assessments–mean (n, SEM) | Sham | Active | Sham | Active | Sham | Active | F | P | F | P | F | P |
| Per-protocol analysis | ||||||||||||
| MADRS | 29.1 (33, 0.8) | 28.9 (32, 0.8) | 24.4 (33, 1.0) | 24.8 (32, 1.1) | 22.1 (34, 1.2) | 23.7 (32, 1.3) | 0.24 | .630 | 41.73 | <.001 | 0.82 | .445 |
| BDI-II | 32.6 (31, 1.7) | 33.2 (28, 1.8) | 25.2 (34, 1.9) | 27.2 (32, 2.0) | 22.1 (32, 1.9) | 24.9 (31, 2.0) | 0.72 | .399 | 24.56 | <.001 | 0.46 | .762 |
| CGI-I | – | – | 3.5 (33, 0.1) | 3.6 (32, 0.1) | 3.1 (33, 0.1) | 3.4 (32, 0.1) | 2.24 | .140 | 12.69 | <.001 | 2.10 | .153 |
| Q-LES-SF | 32.4 (34, 1.9) | 36.0 (30, 2.1) | – | – | 43.5 (32, 2.8) | 43.9 (31, 2.9) | 0.45 | .503 | 31.67 | <.001 | 0.84 | .362 |
| Intention-to-treat analysis | ||||||||||||
| MADRS | 29.1 (34, 0.8) | 29.0 (34, 0.8) | 24.4 (33, 1.0) | 24.8 (34, 1.1) | 22.1 (34, 1.2) | 23.7 (32 1.3) | 0.29 | .593 | 43.09 | <.001 | 0.77 | .467 |
| BDI-II | 32.4 (32, 1.6) | 33.4 (30, 1.7) | 24.9 (34, 1.9) | 27.1 (34, 2.0) | 21.9 (32, 1.9) | 25.1 (31, 2.0) | 1.07 | .306 | 25.07 | <.001 | 0.58 | .678 |
| CGI-I | – | – | 3.5 (33, 0.1) | 3.6 (34, 0.1) | 3.1 (33, 0.1) | 3.4 (32, 0.1) | 2.60 | .112 | 13.07 | <.001 | 1.98 | .165 |
| Q-LES-SF | 32.5 (35, 1.8) | 35.8 (32, 2.0) | – | – | 43.6 (32, 2.8) | 43.8 (31, 2.9) | 0.37 | .545 | 32.00 | <.001 | 0.80 | .376 |
Abbreviations: BDI-II, Beck Depression Inventory; CGI-I, Clinician Global Impression Improvement scale, a 7-point clinician-rated scale ranked from 1-very much improved to 7-very much worse; MADRS, Montgomery-Asberg Depression Rating Scale; MERM, mixed-effects repeated measures; Q-LES-SF, Quality of Life Enjoyment and Satisfaction Questionnaire—Short Form.
Estimated marginal means and results from MERM analyses during the sham-controlled phase. MERM analyses were performed including the following covariates: Maudsley staging method total score as a measure of treatment resistance, and antidepressant use. Statistically significant P values (< .05) are highlighted in bold.