Transcranial magnetic stimulation in the acute treatment of major depressive disorder: clinical response in an open-label extension trial.
BACKGROUND
This report describes the results of an open-label extension study of active trans-cranial magnetic stimulation (TMS) in medication-resistant patients with major depressive disorder who did not benefit from an initial course of therapy in a previously reported 6-week, randomized controlled study of active versus sham TMS.


METHODS
Patients with DSM-IV-defined major depressive disorder were actively enrolled in the study from February 2004 through September 2005 and treated with left prefrontal TMS administered 5 times per week at 10 pulses per second, at 120% of motor threshold, for a total of 3000 pulses/session. The primary outcome was the baseline to endpoint change score on the Montgomery-Asberg Depression Rating Scale (MADRS).


RESULTS
In those patients who received sham in the preceding randomized controlled trial (N = 85), the mean reduction in MADRS scores after 6 weeks of open-label active TMS was -17.0 (95% CI = -14.0 to -19.9). Further, at 6 weeks, 36 (42.4%) of these patients achieved response on the MADRS, and 17 patients (20.0%) remitted (MADRS score < 10). For those patients who received and did not respond to active TMS in the preceding randomized controlled trial (N = 73), the mean reduction in MADRS scores was -12.5 (95% CI = -9.7 to -15.4), and response and remission rates were 26.0% and 11.0%, respectively, after 6 weeks of additional open-label TMS treatment.


CONCLUSIONS
This open-label study provides further evidence that TMS is a safe and effective treatment of major depressive disorder. Furthermore, continued active TMS provided additional benefit to some patients who failed to respond to 4 weeks of treatment, suggesting that longer courses of treatment may confer additional therapeutic benefit.


BACKGROUND
clinicaltrials.gov Identifier: NCT00104611.
Avery
David H
DH
Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Harborview Medical Center, Seattle, WA 98104-2499, USA.
Isenberg
Keith E
KE
Sampson
Shirlene M
SM
Janicak
Philip G
PG
Lisanby
Sarah H
SH
Maixner
Daniel F
DF
Loo
Colleen
C
Thase
Michael E
ME
Demitrack
Mark A
MA
George
Mark S
MS
D000293:Adolescent; D000328:Adult; D000368:Aged; D003072:Cognition Disorders / Q000175:diagnosis / Q000453:epidemiology; D003865:Major Depressive Disorder / Q000628:therapy*; D039721:Diagnostic and Statistical Manual of Mental Disorders; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D012074:Remission Induction; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D050781:Transcranial Magnetic Stimulation / Q000379:methods*; D016896:Treatment Outcome