Elsevier

Biological Psychiatry

Volume 59, Issue 2, 15 January 2006, Pages 187-194
Biological Psychiatry

Original article
A Controlled Study of Repetitive Transcranial Magnetic Stimulation in Medication-Resistant Major Depression

https://doi.org/10.1016/j.biopsych.2005.07.003Get rights and content

Background

Repetitive transcranial magnetic stimulation (TMS) as a treatment for depression has shown statistically significant effects, but the clinical significance of these effects has been questioned.

Methods

Patients with medication-resistant depression were randomized to receive 15 sessions of active or sham repetitive TMS delivered to the left dorsolateral prefrontal cortex at 110% the estimated prefrontal cortex threshold. Each session consisted of 32 trains of 10 Hz repetitive TMS delivered in 5-second trains. The primary end point was treatment response defined as a ≥50% decrease in Hamilton Depression Rating Scale (HDRS) score at both 1 and 2 weeks following the final repetitive TMS treatment. Remission was defined as a HDRS score <8.

Results

The response rate for the TMS group was 30.6% (11/35), significantly (p = .008) greater than the 6.1% (2/33) rate in the sham group. The remission rate for the TMS group was 20% (7/35), significantly (p = .033) greater than the 3% (1/33) rate in the sham group. The HDRS scores showed a significantly (p < .002) greater decrease over time in the TMS group compared with the sham group.

Conclusions

Transcranial magnetic stimulation can produce statistically and clinically significant antidepressant effects in patients with medication-resistant major depression.

Section snippets

Patients

The study procedures were approved by the Human Subjects Review Committee of the University of Washington. In addition, an Investigational Device Exemption was received from the U.S. Food and Drug Administration. All subjects gave written informed consent to participate in the study. The subjects were judged to have capacity to give informed consent by a board-certified psychiatrist. We carefully assessed the subjects for suicide risk and excluded subjects with active suicidal ideation or a

Treatment Efficacy

The TMS group had a significantly greater response rate, 30.6% (11/35), compared with 6.1% (2/33) in the sham group (Fisher’s p = .008, effect size = .69). The TMS group had a significantly greater remission rate, 20.0% (7/35), compared with 3.0% (1/33) in the sham group (Fisher’s p = .033, effect size = .58) (see Figure 2).

Logistic regression analyses, adjusting for the stratification variables, resulted in similar findings: the TMS group had significantly greater odds of response (adjusted

Discussion

In the largest sham-controlled study to date of high-frequency repetitive TMS as a treatment for medication-resistant depression, the response rates and remission rates were higher in the TMS group compared with the sham group. In addition, the HDRS and BDI score changes over time in the two groups indicated superiority of TMS over sham. There was no evidence of any cognitive compromise or adverse effects on neuropsychological functioning with TMS compared with sham, consistent with other

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