Table 2. Effect of rTMS Treatment on Major Study Outcomes Using the Intention-to-Treat Sample.
| Outcome | Baseline | End of rTMS Treatment | End of 24-Wk Follow-up | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Active (n = 81) | Sham (n = 83) | Active (n = 73) | Sham (n = 77) | Adjusted Effect Estimate (95% CI)a | P Value | Active (n = 60) | Sham (n = 65) | Adjusted Effect Estimate (95% CI)a | P Value | |
| Depression symptom remission rate, No. (%) | ||||||||||
| HRSD Remission rateb | NA | NA | 33 (40.7) | 31 (37.4) | 1.16 (0.59 to 2.26) |
.67 | 16 (19.8) | 13 (15.7) | 1.55 (0.62 to 3.86) |
.35 |
| HRSD remission rateb for MDD without PTSD | NA | NA | 20 (48.8) | 18 (42.9) | 1.82 (0.68 to 4.93) |
.23 | 14 (34.2) | 10 (23.8) | 2.69 (0.86 to 8.4) |
.09 |
| HRSD Remission rateb for MDD with PTSD | NA | NA | 13 (32.5) | 13 (31.7) | 0.73 (0.25 to 2.16) |
.56 | 2 (5.0) | 3 (7.3) | 0.73 (0.09 to 5.7) |
.76 |
| Depression symptoms severity, mean (SD) | ||||||||||
| HRSD score | 26.2 (4.9) | 27.5 (5.1) | 14.8 (9.1) | 14.4 (8.6) | 1.28 (−1.42 to 3.97) |
.34 | 16.3 (9.5) | 17.1 (8.9) | 0.67 (−2.59 to 3.94) |
.68 |
| MADRS score | 24.7 (7.6) | 26.2 (6.9) | 14.3 (11.1) | 13.1 (10.5) | 2.26 (−0.91 to 5.44) |
.16 | 13.7 (10.2) | 15.0 (9.7) | − 0.03 (−3.45 to 3.39) |
.99 |
| BDI score | 22.6 (10.3) | 26.5 (10.0) | 14.2 (10.9) | 13.0 (9.5) | 2.22 (−0.64 to 5.08) |
.12 | 9.0 (8.3) | 12.8 (10.8) | − 1.59 (−6.08 to 2.89) |
.48 |
| Suicidality | ||||||||||
| BSI score, mean (SD) | 3.7 (6.0) | 5.6 (6.7) | 2.0 (4.6) | 2.7 (4.9) | 0.08 (−1.46 to 1.62) |
.91 | 1.5 (4.2) | 2.5 (4.9) | − 0.54 (−2.25 to 1.17) |
.53 |
| Suicidal ideation based on CSSRS, No. (%) | 49 (60.5) | 51 (61.5) | 18 (25.7) | 21 (28.8) | 0.90 (0.40 to 2.00) |
.79 | 14 (24.6) | 15 (23.8) | 1.02 (0.43 to 2.46) |
.96 |
| PTSD symptom severity, mean (SD) | ||||||||||
| CAPS score | 32.0 (31.3) | 34.1 (32.2) | 26.9 (28.2) | 23.3 (27.6) | 5.20 (−0.49 to 10.89) |
.07 | 26.7 (28.6) | 21.3 (23.9) | 4.47 (−0.69 to 9.64) |
.09 |
| PCL-M score | 42.2 (17.4) | 43.3 (18.8) | 37.0 (16.9) | 35.2 (16.7) | 2.68 (−0.84 to 6.19) |
.13 | 37.4 (17.4) | 35.2 (16.0) | 2.68 (−1.49 to 6.85) |
.21 |
| Quality of life, mean (SD) | ||||||||||
| VR-36 standardized PCS | 42.4 (11.5) | 40.2 (10.0) | 41.9 (10.9) | 41.2 (11.9) | −1.32 (−3.61 to 0.97) |
.27 | 42.8 (10.8) | 40.1 (12.3) | 0.08 (−2.67 to 2.83) |
.96 |
| VR-36 standardized MCS | 27.2 (11.6) | 25.1 (10.0) | 35.1 (14.3) | 36.0 (14.7) | −1.76 (−5.91 to 2.39) |
.40 | 34.5 (12.8) | 34.8 (13.4) | −0.12 (−4.48 to 4.24) |
.96 |
Abbreviations: BDI, Beck Depression Inventory; BSI, Beck Scale for Suicide Ideation; CAPS, Clinician-Administered PTSD Scale for DSM-IV; CSSRS, Columbia Suicide Severity Rating Scale; HRSD, Hamilton Rating Scale for Depression; MADRS, Montgomery-Åsberg Depression Rating Scale; MCS, mental component scale; MDD, major depressive disorder; NA, not applicable; PCL-M, PTSD Checklist–Military; PCS, physical component scale; PTSD, posttraumatic stress disorder; rTMS, repetitive transcranial magnetic stimulation; VR-36, Veterans RAND 36-item Health Survey.
Treatment effects of rTMS estimated from logistic regressions for binary outcomes adjusted for PTSD, substance use, and site; estimated from general linear regressions for continuous outcomes adjusted for baseline; and presented in the Table as odds ratios (95% CI from the logistic regressions and treatment coefficients (95% CI) from the general linear regressions.
The HRSD remission rates were calculated based on 164 randomized participants. If the HRSD score was missing, the participant was considered as not achieving remission based on the protocol.