Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial.
BACKGROUND
We tested whether transcranial magnetic stimulation (TMS) over the left dorsolateral prefrontal cortex (DLPFC) is effective and safe in the acute treatment of major depression.


METHODS
In a double-blind, multisite study, 301 medication-free patients with major depression who had not benefited from prior treatment were randomized to active (n = 155) or sham TMS (n = 146) conditions. Sessions were conducted five times per week with TMS at 10 pulses/sec, 120% of motor threshold, 3000 pulses/session, for 4-6 weeks. Primary outcome was the symptom score change as assessed at week 4 with the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary outcomes included changes on the 17- and 24-item Hamilton Depression Rating Scale (HAMD) and response and remission rates with the MADRS and HAMD.


RESULTS
Active TMS was significantly superior to sham TMS on the MADRS at week 4 (with a post hoc correction for inequality in symptom severity between groups at baseline), as well as on the HAMD17 and HAMD24 scales at weeks 4 and 6. Response rates were significantly higher with active TMS on all three scales at weeks 4 and 6. Remission rates were approximately twofold higher with active TMS at week 6 and significant on the MADRS and HAMD24 scales (but not the HAMD17 scale). Active TMS was well tolerated with a low dropout rate for adverse events (4.5%) that were generally mild and limited to transient scalp discomfort or pain.


CONCLUSIONS
Transcranial magnetic stimulation was effective in treating major depression with minimal side effects reported. It offers clinicians a novel alternative for the treatment of this disorder.
O'Reardon
John P
JP
Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Philadelphia, PA 19014, USA.
Solvason
H Brent
HB
Janicak
Philip G
PG
Sampson
Shirlene
S
Isenberg
Keith E
KE
Nahas
Ziad
Z
McDonald
William M
WM
Avery
David
D
Fitzgerald
Paul B
PB
Loo
Colleen
C
Demitrack
Mark A
MA
George
Mark S
MS
Sackeim
Harold A
HA
D000293:Adolescent; D000328:Adult; D000368:Aged; D001299:Audiometry; D003865:Major Depressive Disorder / Q000523:psychology / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D050781:Transcranial Magnetic Stimulation / Q000009:adverse effects / Q000295:instrumentation; D016896:Treatment Outcome