Table 1.
Demographics and primary/secondary outcomes by group.
| Overall (N = 46) | Sham iTBS (n = 22) | Active iTBS (n = 24) | |
|---|---|---|---|
| Demographics | |||
| Age, Mean (SD) | 51.0 (12.3) | 53.6 (11.0) | 48.5 (13.1) |
| Females, N (%) | 7 (15.2%) | 3 (13.6%) | 4 (16.7%) |
| Primary outcome | |||
| Clinical relapse, N (%) | 22 (47.8%) | 14 (63.6%) | 8 (33.3%) |
| TMS retreatment | 18 (39.1%) | 11 (50.0%) | 7 (29.2%) |
| Psychiatric hospitalizations | 3 (6.5%) | 2 (9.1%) | 1 (4.2%) |
| Suicide attempts | 0 | 0 | 0 |
| Death | 1 (2.22%)a | 1 (4.5%)a | 0 |
| Days to clinical relapse, Mean (SE) | 241.4 (20.9) | 182.0 (31.9) | 296.0 (22.1) |
| Secondary outcomes | |||
| Medication changes, N (%) | |||
| Medication additions | 12 (26.1%) | 5 (22.7%) | 7 (29.2%) |
| Medication reductions | 11 (23.9%) | 4 (18.1%) | 7 (29.2%) |
| Medication class switch | 2 (4.3%) | 1 (4.5%) | 1 (4.2%) |
| Change PRN benzo/antipsych | 5 (10.9%) | 2 (9.1%) | 3 (12.5%) |
| Clinical TMS retreatment, N (%) | 7 (15.2%) | 3 (13.6%) | 4 (16.7%) |
| Δ No-shows/cancel, Mean (SD) | 0.52 (5.42) | 1.41 (5.53) | −0.29 (5.31) |
Groups are described further based on their original randomization; those randomized to sham received two weeks of active stimulation (i.e., two weeks of sham followed by two weeks of active iTBS), whereas those randomized to active stimulation received four weeks of active iTBS. Please see Fig. 1 for statistical reporting related to all-cause relapse rates (significant at p < 0.015); there were no significant group differences in secondary outcomes.
iTBS intermittent theta burst stimulation, SD standard deviation, SE standard error, PRN as needed, benzo benzodiazepines, antipsych antipsychotics
aDeath from overdose