背景:尽管双相抑郁有一些一线治疗选择,没有一个是速效的。一个新的rTMS协议,斯坦福加速智能神经调节治疗(SAINT®)已被证明在重度抑郁症(MDD)中具有快速的抗抑郁作用。我们检查了初步的安全性,耐受性,SAINT对治疗难治性双相I型障碍患者的小样本抑郁症的治疗效果。
方法:目前正在经历中度至重度抑郁症的治疗抗性双相I型障碍参与者接受开放标签SAINT治疗。静息状态功能磁共振成像(fMRI)用于根据左背外侧前额叶皮质与后代前扣带回皮质最相关的区域为每个参与者生成个性化的治疗目标。参与者每天接受10次iTBS治疗,间隔50分钟,连续5天。主要结果是蒙哥马利-奥斯贝格抑郁量表(MADRS)从基线到治疗后立即随访的变化。
结果:我们治疗了10名参与者,发现MADRS评分平均降低了16.9,治疗后立即有50%的反应率和40%的缓解率。60%的参与者在治疗后1个月内达到缓解标准。无严重不良事件,躁狂发作,或观察到认知副作用。
结论:我们的研究样本量有限,需要更大的样本来确认安全性和有效性。
结论:SAINT已显示出初步可行性,安全,耐受性,和治疗难治性双相I型抑郁症的疗效。需要使用更大样本的双盲假对照试验来确认安全性和有效性。
BACKGROUND: Although there are a few first-line treatment options for bipolar depression, none are rapid-acting. A new rTMS protocol, Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®), has been shown to have a rapid antidepressant effect in major depressive disorder (MDD). We examined the preliminary safety, tolerability, and efficacy of SAINT for the treatment of depression in a small sample of persons with treatment-resistant bipolar I disorder.
METHODS: Participants with treatment-resistant bipolar I disorder currently experiencing moderate to severe depression were treated with open-label SAINT. Resting-state functional MRI (fMRI) was used to generate individualized treatment targets for each participant based on the region of the left dorsolateral prefrontal cortex most anticorrelated with the subgenual anterior cingulate cortex. Participants were treated with 10 iTBS sessions daily, with 50-min intersession intervals, for up to 5 consecutive days. The primary outcome was change in Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to immediate follow-up after treatment.
RESULTS: We treated 10 participants and found a mean reduction of 16.9 in MADRS scores, with a 50 % response rate and 40 % remission rate immediately following treatment. 60 % of participants met remission criteria within the 1-month period following treatment. No serious adverse events, manic episodes, or cognitive side effects were observed.
CONCLUSIONS: Our
study has a limited sample size and larger samples are needed to confirm safety and efficacy.
CONCLUSIONS: SAINT has shown preliminary feasibility, safety, tolerability, and efficacy in treating treatment-resistant bipolar I depression. Double-blinded sham-controlled trials with larger samples are needed to confirm safety and efficacy.