UC Berkeley Press Release
Efficacy and Safety of Transcranial Magnetic Stimulation in the Acute Treatment of Major Depression: A Multisite Randomized Controlled Trial
Eficacia e segurança da Estimulacao Magnetica Transcraniana no tratamento agudo da Depressao Maior: Estudo clinico randomizado multicentrico.
John P. O'Reardon a , H. Brent Solvason b , Philip G. Janicak c , Shirlene Sampson d , Keith E. Isenberg e , Ziad Nahas j , William M. McDonald f , David Avery g , Paul B. Fitzgerald h , Colleen Loo i , Mark A. Demitrack k , Mark S. George j and Harold A. Sackeim l
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.
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.
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.
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.
Key Words: Clinical trial; efficacy; major depression; safety; TMS