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.
BACKGROUND
Although transcranial magnetic stimulation (TMS) can be an effective acute antidepressant treatment, few studies systematically examine persistence of benefit.


OBJECTIVE
We assessed the durability of antidepressant effect after acute response to TMS in patients with major depressive disorder (MDD) using protocol-specified maintenance antidepressant monotherapy.


METHODS
Three hundred one patients were randomly assigned to active or sham TMS in a 6-week, controlled trial. Nonresponders could enroll in a second, 6-week, open-label study. Patients who met criteria for partial response (i.e., >25% decrease from the baseline HAMD 17) during either the sham-controlled or open-label study (n = 142) were tapered off TMS over 3 weeks, while simultaneously starting maintenance antidepressant monotherapy. Patients were then followed for 24 weeks in a naturalistic follow-up study examining the long-term durability of TMS. During this durability study, TMS was readministered if patients met prespecified criteria for symptom worsening (i.e., a change of at least one point on the CGI-S scale for 2 consecutive weeks). Relapse was the primary outcome measure.


RESULTS
Ten of 99 (10%; Kaplan-Meier survival estimate = 12.9%) patients relapsed. Thirty-eight (38.4%) patients met criteria for symptom worsening and 32/38 (84.2%) reachieved symptomatic benefit with adjunctive TMS. Safety and tolerability were similar to acute TMS monotherapy.


CONCLUSIONS
These initial data suggest that the therapeutic effects of TMS are durable and that TMS may be successfully used as an intermittent rescue strategy to preclude impending relapse.
Janicak
Philip G
PG
Department of Psychiatry, Rush University Medical Center, Chicago, Illinois 60612, USA. pjanicak@rush.edu
Nahas
Ziad
Z
Lisanby
Sarah H
SH
Solvason
H Brent
HB
Sampson
Shirlene M
SM
McDonald
William M
WM
Marangell
Lauren B
LB
Rosenquist
Peter
P
McCall
W Vaughn
WV
Kimball
James
J
O'Reardon
John P
JP
Loo
Colleen
C
Husain
Mustafa H
MH
Krystal
Andrew
A
Gilmer
William
W
Dowd
Sheila M
SM
Demitrack
Mark A
MA
Schatzberg
Alan F
AF
D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use; D003865:Major Depressive Disorder / Q000517:prevention & control* / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D050781:Transcranial Magnetic Stimulation / Q000379:methods*; D016896:Treatment Outcome
D000928:Antidepressive Agents