Table 2. Primary Outcomea.
Double active | tDCS only | Double sham | |
---|---|---|---|
HDRS-17 scores at various time points, mean (SD)b | |||
Baseline | 21.0 (3.3) | 20.8 (3.5) | 20.8 (3.3) |
Week 2 | 14.5 (4.4) | 14.5 (4.7) | 13.4 (5.4) |
Week 3 | 13.0 (5.0) | 13.4 (5.3) | 13.5 (5.5) |
Week 4 | 13.5 (5.8) | 13.1 (5.7) | 13.3 (6.4) |
Week 6 | 12.8 (5.0) | 12.4 (5.1) | 13.0 (6.2) |
Response/remission rates at various time points, No. (%)c | |||
Baseline | NA | NA | NA |
Week 2 | 12 (19)/5 (8) | 13 (18)/6 (8) | 20 (28)/12 (17) |
Week 3 | 21 (33)/10 (16) | 21 (30)/9 (13) | 23 (32)/9 (12) |
Week 4 | 24 (38)/8 (13) | 19 (28)/10 (14) | 24 (33)/15 (21) |
Week 6 | 20 (31)/9 (14) | 26 (36)/13 (18) | 28 (38)/15 (21) |
Change in HDRS-17 score per wk, β (95% CI)d | −1.30 (−1.55 to −1.04) | −1.33 (−1.57 to −1.09) | −1.17 (−1.41 to −0.93) |
Abbreviations: HDRS-17, Hamilton Depression Rating Scale 17-item version; tDCS, transcranial direct current stimulation.
The estimated effect sizes between groups were as follows: double active vs tDCS only (Cohen d, 0.05; 95% CI, −0.48 to 0.58; P = .86), double active vs double sham (Cohen d,−0.20; 95% CI, −0.73 to 0.34; P = .47), and tDCS only vs double sham (Cohen d, −0.25; 95% CI, −0.76 to 0.27; P = .35). Group comparisons represent estimated differences in HDRS-17 change per week between groups.
HDRS-1720 scores range from 0-52; minimally significant score, 0-7; remission, ≤7.
Response was defined as a ≥50% decrease in baseline HDRS-17 score and remission as an HDRS-17 score ≤7.
β Values are model estimations of changes in HDRS-17 scores for 1 week.