Key Takeaways
Extended Takeaways
- The protocol mirrored a standard unipolar depression regimen: left DLPFC stimulation at 120% of the subject’s RMT, 10 Hz for a 4-second train with a 26-second intertrain interval, 3,000 pulses per session, 5 times a week for a total of 35 treatments or until remission.
- Symptom improvement was not limited to the primary outcome; MADRS, HDRS, CGI-S, and QIDS all improved from pretreatment to posttreatment, all P < .001, with the largest reductions toward response and remission occurring after 4 weeks from baseline.
- Retention was high, with 29 of 31 patients completing treatment; one patient discontinued after 1 week because of feeling uncomfortably stimulated, and one stopped because daily treatment attendance was not feasible.
- No treatment-emergent mania or hypomania was detected during treatment, and YMRS scores improved over time, which is clinically relevant when considering neuromodulation in bipolar depression alongside ongoing mood-stabilizing treatment.
- Concurrent medication appeared to matter: lamotrigine was associated with lower MADRS scores in univariate and post hoc multivariate models (−3.84 ± 1.26, P = .01; −2.59 ± 1.27, P = .05), whereas lithium was associated with higher MADRS scores (4.05 ± 1.27, P = .003; 3.46 ± 1.34, P = .02).
- Suicidal ideation also declined over the course of treatment, with C-SSRS scores decreasing from 3.74 to 0.75, suggesting potential benefit on an outcome of particular concern in bipolar disorder.
