松田 勇紀

Repetitive transcranial magnetic stimulation (rTMS) therapy is an effective treatment for treatment-resistant depression (TRD). However, discrepancies between subjective and objective assessments of treatment responses remain underexplored. This study examined discrepancies between clinician-rated and patient-reported scales following acute-phase rTMS therapy, focusing on item-level symptom improvement. This prospective observational study included 69 participants with TRD (34 females, 35 males) who underwent rTMS therapy at two institutions. Depression severity was assessed using the 17-item Hamilton Rating Scale for Depression (HAMD-17) and Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR). Remission and response rates were compared, and predictors of discrepancies were examined. At week 6, remission rates were significantly higher on the HAMD-17 than on the QIDS-SR (57.3 % vs. 35.2 %, p=0.016), and a similarly for response rates (66.1 % vs. 41.1 %, p=0.006). Symptom analysis showed greater improvements in behavioral and cognitive areas (e.g., work/activity, psychomotor retardation, anxiety). Despite clinically meaningful improvements, discrepancies were prominent in depressed mood, sleep disturbances, somatic symptoms, and suicidal ideation. Patients with higher education and more sessions were more likely to meet objective remission or response criteria without perceiving corresponding subjective improvement. These findings highlight a gap between subjective and objective assessments in rTMS therapy for TRD, with clinician-rated scales showing significantly higher remission and response rates than patient-reported scales. Discrepancies were especially notable in mood, sleep, somatic, and suicidal domains. These findings underscore the importance of integrating both assessment types when evaluating rTMS efficacy and suggest future interventions should optimize stimulation protocols and adopt patient-centered strategies.

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: Bipolar disorder has a long depressive episode and high risk of suicide. In clinical practice, patients often show no response to pharmacotherapy, which results in prolongation of the depressive episode. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive technique expected to serve as a treatment option for bipolar depression. For bipolar depression, a meta-analysis suggested that low-frequency stimulation to the right prefrontal cortex was possibly effective. However, a medium or large sample, randomized, double blind, sham controlled study has not yet been performed. OBJECTIVE: To examine the efficacy and safety of 1-Hz rTMS to the right prefrontal cortex in patients with treatment-resistant bipolar depression. rTMS was approved by the Ministry of Health, Labor, and Welfare as a highly advanced medical technology on March 1, 2019. METHODS: In this multicenter, double-blind, randomized, sham stimulation-controlled trial for bipolar depression, patients will be individually allocated to active or sham stimulation plus usual medication and followed up for 6 months. The conditions of stimulation by the Mag Pro R30 transcranial magnetic stimulation device (Magventure) will be a frequency of 1-Hz, intensity of 120% motor threshold, and duration of 1800 seconds to the right prefrontal cortex 5 days a week for 4 weeks during the acute treatment period. The primary endpoint will be a total change in the Montgomery-Åsberg Depression Rating Scale score during the acute treatment period. DISCUSSION: The outcomes of this study will inform clinical practice for the treatment of bipolar depression. CLINICAL TRIAL REGISTRATION: https://jrct.niph.go.jp/latest-detail/jRCTs032180138, identifier jRCTs032180138.

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.