Durability of clinical benefit with transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant major depression: assessment of relapse during a 6-month, multisite, open-label study.
Level 3 - non-randomized controlled study
Prospective, open-label 24-week follow-up study of treatment responders without a concurrent control group.
PubMed 20965447 · doi:10.1016/j.brs.2010.07.003
What was done
Patients with pharmacoresistant major depressive disorder who achieved at least partial response (>25% reduction in HAMD-17) after 6 weeks of sham-controlled or open-label transcranial magnetic stimulation (TMS; n = 142) were tapered off TMS over 3 weeks while initiating maintenance antidepressant monotherapy. Participants were then followed for 24 weeks in an open-label, multicenter durability study. Patients meeting criteria for symptom worsening (increase of at least one point on the CGI-S scale for 2 consecutive weeks) received adjunctive re-treatment with TMS. The primary outcome was depression relapse.
What was found
Of 99 evaluable patients in the follow-up phase, 10 (10.0%; Kaplan-Meier estimate 12.9%) relapsed over 24 weeks. Thirty-eight patients (38.4%) developed symptom worsening, and 32 of these 38 (84.2%) re-achieved symptomatic benefit following adjunctive TMS rescue therapy. Adverse events and tolerability were reported as comparable to acute TMS monotherapy.
Why it matters
This study suggests that acute clinical improvements following TMS can be maintained over 6 months with maintenance antidepressant monotherapy, and that brief rescue courses of TMS may successfully reverse emerging depressive relapses.
Limits
The durability phase was open-label without a sham or un-retreated control group, making it impossible to isolate the specific effect of rescue TMS from spontaneous recovery or maintenance medication effects. Only 99 of the 142 partial responders were analyzed in the follow-up cohort, and the sample was enriched for treatment responders.
Cited by
- contradicts Transcranial magnetic stimulation (TMS) outcomes for depression show high relapse rates and lack durability beyond 6 months.