松田 勇紀

BACKGROUND: With 30%-50% of people with bipolar depression (BDep) not responding to multiple pharmacological treatments, alternative therapies are needed. Accelerated intermittent theta burst stimulation (aiTBS) over the left dorsolateral prefrontal cortex (L-DLPFC) has been employed for individuals with pharmacological treatment-resistant major depressive disorder (TR-MDD). Imaging studies have revealed reduced regional activity of the L-DLPFC for both TR-MDD and pharmacological treatment-resistant BDep (TR-BDep), suggesting that aiTBS over the L-DLPFC may be beneficial for people with TR-BDep. METHODS: A 6-week, double-blind, sham-controlled, randomized trial will be conducted to compare the efficacy and safety of aiTBS to the L-DLPFC in people with TR-BDep (jRCTs042240019). Fifty iTBS sessions (1800 pulses/session) will be delivered in 10 daily sessions over 5 consecutive days at 90% resting motor threshold. This aiTBS protocol is termed as Fujita Neuromodulation Therapy for Bipolar Depression (FNT-BD). Twenty-two participants (both sexes, aged 18-64 years) with TR-BDep (DSM-5-TR, Type I) will be recruited. The response rate at any given week of follow-up will be the primary efficacy outcome, defined as a reduction of ≥50% in the Montgomery Åsberg Depression Rating Scale (MADRS) score. Other outcomes will include MADRS score changes, remission rate (10 ≥ MADRS score), Clinical Global Impression-Improvement score, Clinical Global Impression-Severity score, discontinuation rate, and incidence of individual adverse events. RESULTS: We anticipate that individuals who receive the aiTBS treatment show significant improvement in depressing symptoms compared to those receiving sham treatment. CONCLUSIONS: This study will provide valuable evidence for both patients with TR-BDep and clinicians.

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Introduction Evidence-based medicine (EBM) competency is crucial for healthcare professionals; however, validated tools to assess EBM skills in Japanese are scarce. This study aimed to develop and validate a Japanese version of the Assessing Competency in EBM (ACE) tool. Methods We translated the ACE tool into Japanese, following international standards, and distributed it online to 99 healthcare professionals and students. The participants completed demographic questions and the Japanese version of the ACE tool. A subset also completed the retest and Fresno test. Internal consistency was assessed using Cronbach's alpha, test-retest reliability using the intraclass correlation coefficient (ICC), and construct validity using a confirmatory factor analysis and correlation with the Fresno test. Results The Japanese version of the ACE tool showed a low internal consistency (Cronbach's alpha = 0.31, 95% CI: 0.09-0.49), but an acceptable test-retest reliability (ICC = 0.64, 95% CI: 0.40-0.81). A confirmatory factor analysis provided moderate support for the structure of the tool (SRMR = 0.092, RMSEA = 0.048, CFI = 0.852). The tool demonstrated a moderate correlation with the Fresno test (r = 0.35). The median completion time was 847 s (IQR, 577-1,249 s). Conclusion Although the Japanese version of the ACE tool showed some promising aspects, including a quick administration and partial validity, its low internal consistency suggests that refinement is needed before it can be confidently used in Japanese medical education settings. Future studies should focus on improving the tool's reliability, potentially through in-person administration, to develop a robust EBM assessment tool in the Japanese healthcare context.

The objective of this study was to reveal the effectiveness of repetitive transcranial magnetic stimulation (rTMS) for Japanese patients with treatment-resistant depression (TRD) in clinical practice, based on real-world data from a nationwide multicenter observational study in Japan. Clinical data of patients with TRD treated with rTMS (NeuroStar TMS treatment system) under public insurance coverage were retrospectively collected from 21 institutes nationwide between June 2019 and December 2023. Depression severity was assessed by the 17-item Hamilton Depression Rating Scale (HAMD-17). Response and remission were defined as ≥50 % reduction from baseline and ≤7 points on the HAMD-17, respectively. The primary outcome was the changes in the HAMD-17 score from baseline to the endpoint following rTMS. Data from 497 patients with TRD were candidates for this study. The HAMD-17 scores (mean (SD)) improved significantly from 18.9 (5.3) to 9.7 (6.6), respectively. The response and remission rates at the end of rTMS therapy as assessed by the HAMD-17 were 53.5 % and 42.8 %, respectively. The dropout rate due to adverse effects was 4.2 %, and the treatment was generally well tolerated. No convulsive seizures or manic changes were observed. These results indicate that conventional rTMS is effective and safe in Japanese patients with TRD.

AIM: This study aimed to elucidate the effects of repetitive transcranial magnetic stimulation (rTMS) on weight, body mass index (BMI), and lipid metabolism in patients with treatment-resistant depression (TRD). METHODS: This retrospective observational study included patients with TRD who received rTMS treatment at the Jikei University Hospital from September 2018 to August 2021. The patients were diagnosed based on the DSM-5 and ICD-10 criteria and treated using the NeuroStar TMS System. For 3-6 weeks, 10-Hz rTMS was administered to the left dorsolateral prefrontal cortex at 120% motor threshold. The primary outcomes were changes in weight and BMI, whereas the secondary outcomes included changes in total, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) cholesterol levels, thyroid function indicators, as well as HAMD-17, HAMD-24, and Montgomery-Åsberg Depression Rating Scale (MADRS) scores. Statistical analysis was conducted using paired t-tests and repeated measures ANOVA. RESULTS: Among the 34 patients (20 men and 14 women) included, no significant changes were observed in weight or BMI after rTMS treatment (average weight reduction: -0.50 kg, 95% CI: -0.14 to 0.56, p = 0.24; average BMI reduction: -0.21, 95% CI: -0.10 to 0.61, p = 0.15). However, significant reductions in total, HDL, and LDL cholesterol levels and FT4 were observed. Furthermore, the HAMD-17, HAMD-24, and MADRS scores significantly increased post-treatment. CONCLUSION: rTMS treatment did not affect weight or BMI in patients with TRD but is believed to improve lipid metabolism.