Scholarlink

Background <p>Dorsomedial prefrontal cortex repetitive transcranial magnetic stimulation (DMPFC-rTMS) has shown some evidence of an antidepressant effect. This study aimed to examine the efficacy and safety of DMPFC-rTMS as a combination strategy with concurrently initiated selective serotonin reuptake inhibitors (SSRIs) compared with conventional high-frequency left-prefrontal rTMS (HF-rTMS) + SSRI or sham stimulation + SSRI.</p> Methods <p>In this prospective, single-center, six-week, randomized, three-arm, double-blind, sham- and active-comparator-controlled trial, patients with a current episode of major depressive disorder (MDD) were randomly allocated in a 1:1:1 ratio to receive either DMPFC-rTMS (20 sessions, 110% motor threshold, 2000 pulses), HF-rTMS (20 sessions, 110% motor threshold, 2000 pulses), or sham stimulation, all in combination with a concurrently initiated SSRI. The primary outcome was the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score at week six of the study. The secondary outcomes included changes in subjective assessment; response, remission, and dropout rates; and side effects of both rTMS and antidepressant treatment.</p> Results <p>Sixty patients (20 per group) were randomized and included in the analysis. The mean change in the MADRS total score from baseline to week 6 was −14.3 points (95% confidence interval [CI]: −18.3, −10.3) in the DMPFC-rTMS group, −8.2 points (95% CI: −11.7, −4.7) in the HF-rTMS group, and −12.6 points (95% CI: −16.1, −9.0) in the sham group. However, no pairwise comparisons between these groups reached statistical significance. The response/remission rates (DMPFC-rTMS: 35%/20%; HF-rTMS: 30%/15%; sham: 55%/45%) and the dropout rates (45%, 25%, and 25%, respectively) did not differ significantly between the groups. No serious adverse events occurred.</p> Conclusions <p>This study did not demonstrate superior efficacy of DMPFC-rTMS or HF-rTMS over sham stimulation when initiated concurrently with SSRIs. These findings should be interpreted as exploratory. The trial was underpowered to detect the likely incremental effect of adding rTMS to a concurrently initiated SSRI and was further limited by a high sham response and differential attrition in the DMPFC-rTMS arm. Optimal stimulation parameters and patient selection require further validation.</p> Trial registration <p>ISRCTN26184028 (Registered retrospectively, July 26, 2022).</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Dorsomedial prefrontal cortex repetitive transcranial magnetic stimulation combined with antidepressants in major depressive disorder: a randomized, double-blind, single-center, sham-controlled trial

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年8月4日

查看全文
  • Martin Bares,
  • Monika Klirova,
  • Martin Hejzlar,
  • Nina Biackova,
  • Martin Brunovsky,
  • Lenka Kostylkova,
  • Tomas Novak

摘要

Background

Dorsomedial prefrontal cortex repetitive transcranial magnetic stimulation (DMPFC-rTMS) has shown some evidence of an antidepressant effect. This study aimed to examine the efficacy and safety of DMPFC-rTMS as a combination strategy with concurrently initiated selective serotonin reuptake inhibitors (SSRIs) compared with conventional high-frequency left-prefrontal rTMS (HF-rTMS) + SSRI or sham stimulation + SSRI.

Methods

In this prospective, single-center, six-week, randomized, three-arm, double-blind, sham- and active-comparator-controlled trial, patients with a current episode of major depressive disorder (MDD) were randomly allocated in a 1:1:1 ratio to receive either DMPFC-rTMS (20 sessions, 110% motor threshold, 2000 pulses), HF-rTMS (20 sessions, 110% motor threshold, 2000 pulses), or sham stimulation, all in combination with a concurrently initiated SSRI. The primary outcome was the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score at week six of the study. The secondary outcomes included changes in subjective assessment; response, remission, and dropout rates; and side effects of both rTMS and antidepressant treatment.

Results

Sixty patients (20 per group) were randomized and included in the analysis. The mean change in the MADRS total score from baseline to week 6 was −14.3 points (95% confidence interval [CI]: −18.3, −10.3) in the DMPFC-rTMS group, −8.2 points (95% CI: −11.7, −4.7) in the HF-rTMS group, and −12.6 points (95% CI: −16.1, −9.0) in the sham group. However, no pairwise comparisons between these groups reached statistical significance. The response/remission rates (DMPFC-rTMS: 35%/20%; HF-rTMS: 30%/15%; sham: 55%/45%) and the dropout rates (45%, 25%, and 25%, respectively) did not differ significantly between the groups. No serious adverse events occurred.

Conclusions

This study did not demonstrate superior efficacy of DMPFC-rTMS or HF-rTMS over sham stimulation when initiated concurrently with SSRIs. These findings should be interpreted as exploratory. The trial was underpowered to detect the likely incremental effect of adding rTMS to a concurrently initiated SSRI and was further limited by a high sham response and differential attrition in the DMPFC-rTMS arm. Optimal stimulation parameters and patient selection require further validation.

Trial registration

ISRCTN26184028 (Registered retrospectively, July 26, 2022).