Wada Masataka, Nakajima Shinichiro, Taniguchi Keita, Honda Shiori, Mimura Yu, Takemura Ryo, Thorpe Kevin E, Tsugawa Sakiko, Tarumi Ryosuke, Moriyama Sotaro, Arai Naohiro, Kitahata Ryosuke, Uchida Hiroyuki, Koike Shinsuke, Daskalakis Zafiris J, Mimura Masaru, Blumberger Daniel M, Noda Yoshihiro
Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA; Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan.
Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan.
Brain Stimul. 2025 Jan-Feb;18(1):25-33. doi: 10.1016/j.brs.2024.12.1474. Epub 2024 Dec 25.
Bilateral repetitive transcranial magnetic stimulation (BL-rTMS) over the dorsolateral prefrontal cortex is effective for treatment-resistant depression (TRD). Owing to a shorter treatment time, bilateral theta burst stimulation (BL-TBS) can be more efficient protocol. The non-inferiority of BL-TBS to BL-rTMS was established in late-life TRD; however, this has not been determined in adults of other age groups. Therefore, we investigated the non-inferiority in efficacy of BL-TBS versus BL-rTMS for TRD across a wide range of ages in a randomized, single-blind, multicenter trial.
The study included 180 participants with major depressive disorder (moderate or greater severity) who were unresponsive to at least one antidepressant treatment between September 2018 and July 2022. Following venlafaxine treatment, patients were randomly assigned to BL-rTMS or BL-TBS (1:1 ratio). The primary outcome was baseline-adjusted Montgomery-Åsberg Depression Rating Scale scores at 6 weeks. The non-inferiority margin of -3.86 was compared against the baseline-adjusted difference. Secondary outcomes included other depression rating scales.
Seventy-seven patients were randomly assigned to BL-rTMS and 81 to BL-TBS, of whom 73 and 76 were assessed for the primary outcome, respectively. There was a -2.44 point difference, favoring BL-rTMS (one-tailed lower 95 % CI = -4.19, p = 0.091 for non-inferiority), and non-inferiority of BL-TBS was not established. However, non-inferiority was observed for secondary outcomes. The all-cause dropout rates and number of adverse effects were similar between them.
Our study could not establish the non-inferiority of BL-TBS compared to BL-rTMS in terms of efficacy for patients with TRD across the adult lifespan.
双侧重复经颅磁刺激（BL-rTMS）作用于背外侧前额叶皮质对难治性抑郁症（TRD）有效。由于治疗时间较短，双侧theta爆发刺激（BL-TBS）可能是更有效的方案。在老年TRD患者中已证实BL-TBS不劣于BL-rTMS；然而，在其他年龄组的成年人中尚未确定这一点。因此，我们在一项随机、单盲、多中心试验中，研究了BL-TBS与BL-rTMS治疗TRD在广泛年龄范围内疗效的非劣效性。
该研究纳入了180名患有重度抑郁症（中度或更严重）且在2018年9月至2022年7月期间对至少一种抗抑郁治疗无反应的参与者。在接受文拉法辛治疗后，患者被随机分配至BL-rTMS或BL-TBS组（1:1比例）。主要结局是6周时经基线调整的蒙哥马利-Åsberg抑郁评定量表评分。将-3.86的非劣效性界值与经基线调整的差异进行比较。次要结局包括其他抑郁评定量表。
77名患者被随机分配至BL-rTMS组，81名被分配至BL-TBS组，其中分别有73名和76名患者接受了主要结局评估。差异为-2.44分，有利于BL-rTMS（单尾下95%置信区间=-4.19，非劣效性p=0.091），未确立BL-TBS的非劣效性。然而，在次要结局中观察到非劣效性。两组的全因脱落率和不良反应数量相似。
我们的研究未能确立在成年期全阶段TRD患者中，BL-TBS在疗效方面不劣于BL-rTMS。
