Priority CommunicationEfficacy and Safety of Transcranial Magnetic Stimulation in the Acute Treatment of Major Depression: A Multisite Randomized Controlled Trial
Section snippets
Subjects
Eligible subjects were antidepressant medication-free outpatients, aged 18–70, with a DSM-IV diagnosis of MDD, single episode or recurrent, with a current episode duration of 3 years or less. The episode had a Clinical Global Impressions Severity of Illness (CGI-S) score of at least 4 and a total score of at least 20 on the 17-item Hamilton Depression Rating Scale (HAMD17). Symptom stability was required during a 1-week no-treatment lead-in period, with a HAMD17 total score of at least 18 and a
Patient Disposition
Of the 325 patients randomized to TMS or sham, 301 (92.6%) had at least one postbaseline assessment, and their data comprised the a priori–specified analysis set. There were no baseline clinical or demographic differences between the 24 nonevaluable patients and the 301 evaluable subjects. Nonevaluable patients were evenly distributed between the active (n = 10) and the sham (n = 14) conditions, and there was no systematic difference between these groups in the reasons for discontinuation.
Discussion
This is the first large, multisite, randomized controlled trial of daily left prefrontal TMS in medication-free patients with major depression who had failed to receive adequate benefit from prior antidepressant treatment. The findings indicate that TMS, administered at these parameters for a period of 4–6 weeks, is safe and effective in the treatment of major depression.
The pattern of symptom improvement was consistent across the various study outcome measures. Active treatment with TMS was
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