加速间歇θ-猝发刺激与难治性双相抑郁症:随机临床试验。

IF 22.5 1区 医学 Q1 PSYCHIATRY JAMA Psychiatry Pub Date : 2024-09-01 DOI:10.1001/jamapsychiatry.2024.1787
Yvette I Sheline, Walid Makhoul, Alexandra S Batzdorf, Frederick J Nitchie, Kevin G Lynch, Robin Cash, Nicholas L Balderston
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引用次数: 0

摘要

重要性:双相情感障碍(BD)是一种慢性致残性疾病,抑郁症占患病时间的大部分。最近的研究表明,利用间歇θ-脉冲刺激(aiTBS)的加速时间表,经颅磁刺激治疗耐药重度抑郁症(MDD)的临床疗效取得了突破性进展,但这种治疗方法对难治性 BD 的疗效尚不清楚:目的:评估aiTBS对治疗难治性BD的疗效:这项随机临床试验于2022年3月至2024年2月进行,纳入了从宾夕法尼亚大学躁郁症门诊转诊的中重度抑郁发作的难治性BD患者。根据抗抑郁治疗史表标准,纳入的患者之前曾有2次或2次以上抗抑郁试验失败,且无其他原发性精神病诊断,正在接受情绪稳定剂治疗4周或4周以上,蒙哥马利-奥斯伯格抑郁评分量表(MADRS)得分在20分或20分以上:在治疗前,通过静息态功能磁共振成像计算出左侧背外侧前额叶皮层与扣带下前扣带皮层的连通性,从而计算出个性化的左侧背外侧前额叶皮层目标。患者按1:1随机分配到每天10次的成像引导主动或假aiTBS治疗,为期5天,每小时1次,90%静息运动阈值,共90 000次脉冲:主要结果为治疗前后的MADRS重复评分:共有 24 名参与者(女性 12 人 [50%];男性 12 人 [50%];平均 [SD] 年龄 43.3 [16.9] 岁)被随机分配接受活性(n = 12)或假性(n = 12)aiTBS 治疗。所有参与者均完成了治疗和为期 1 个月的随访。治疗结束时,主动组的 MADRS 评分(基线时平均值 [SD] 为 30.4 [4.8];治疗后为 10.5 [6.7])明显低于假体组(基线时平均值 [SD] 为 28.0 [5.4];治疗后为 25.3 [6.7])(估计差异为 -14.75;95% CI,-19.73 至 -9.77;P 结论及相关性:在这项随机临床试验中,对治疗耐药的 BD 患者而言,aiTBS 在减轻抑郁症状方面比假刺激更有效。还需要进一步的试验来确定aiTBS的持久性,并与其他治疗方法进行比较:试验注册:ClinicalTrials.gov Identifier:试验注册:ClinicalTrials.gov Identifier:NCT05228457。
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Accelerated Intermittent Theta-Burst Stimulation and Treatment-Refractory Bipolar Depression: A Randomized Clinical Trial.

Importance: Bipolar disorder (BD) is chronic and disabling, with depression accounting for the majority of time with illness. Recent research demonstrated a transformative advance in the clinical efficacy of transcranial magnetic stimulation for treatment-resistant major depressive disorder (MDD) using an accelerated schedule of intermittent theta-burst stimulation (aiTBS), but the effectiveness of this treatment for treatment-refractory BD is unknown.

Objective: To evaluate the effectiveness of aiTBS for treatment-refractory BD.

Design, setting, and participants: This randomized clinical trial, conducted from March 2022 to February 2024, included individuals with treatment-resistant BD with moderate to severe depressive episodes referred from the Penn Bipolar outpatient clinic. Included patients had 2 or more prior failed antidepressant trials by Antidepressant Treatment History Form criteria and no other primary psychiatric diagnosis, were receiving a mood stabilizer for 4 or more weeks, and had a Montgomery-Åsberg Depression Rating Scale (MADRS) score of 20 or higher.

Intervention: Prior to treatment, resting-state functional magnetic resonance imaging was used to compute personalized left dorsolateral prefrontal cortex target by connectivity to subgenual anterior cingulate cortex. Patients were randomized 1:1 to 10 sessions per day of imaging-guided active or sham aiTBS for 5 days with 1 session per hour at 90% resting motor threshold for 90 000 pulses total.

Main outcome and measures: The main outcome was repeated MADRS scores before and after treatment.

Results: A total of 24 participants (12 [50%] female; 12 [50%] male; mean [SD] age, 43.3 [16.9] years) were randomized to active (n = 12) or sham (n = 12) aiTBS. All participants completed treatment and 1-month follow-up. MADRS scores were significantly lower in the active group (mean [SD], 30.4 [4.8] at baseline; 10.5 [6.7] after treatment) than in the sham group (28.0 [5.4] at baseline; 25.3 [6.7] after treatment) at treatment end (estimated difference, -14.75; 95% CI, -19.73 to -9.77; P < .001; Cohen d, -2.19).

Conclusion and relevance: In this randomized clinical trial, aiTBS was more effective than sham stimulation for depressive symptom reduction in patients with treatment-resistant BD. Further trials are needed to determine aiTBS durability and to compare with other treatments.

Trial registration: ClinicalTrials.gov Identifier: NCT05228457.

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来源期刊
JAMA Psychiatry
JAMA Psychiatry PSYCHIATRY-
CiteScore
30.60
自引率
1.90%
发文量
233
期刊介绍: JAMA Psychiatry is a global, peer-reviewed journal catering to clinicians, scholars, and research scientists in psychiatry, mental health, behavioral science, and related fields. The Archives of Neurology & Psychiatry originated in 1919, splitting into two journals in 1959: Archives of Neurology and Archives of General Psychiatry. In 2013, these evolved into JAMA Neurology and JAMA Psychiatry, respectively. JAMA Psychiatry is affiliated with the JAMA Network, a group of peer-reviewed medical and specialty publications.
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