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Abstract：
BACKGROUND: Anhedonia, which is defined as the inability to feel pleasure, is considered a core symptom of major depressive disorder (MDD). It can lead to several adverse outcomes in adolescents, including heightened disease severity, resistance to antidepressants, recurrence of MDD, and even suicide. Specifically, patients who suffer from anhedonia may exhibit a limited response to selective serotonin reuptake inhibitors (SSRIs) and cognitive behavioral therapy (CBT). Previous researches have revealed a link between anhedonia and abnormalities within the reward circuitry, making the nucleus accumbens (NAc) a potential target for treatment. However, since the NAc is deep within the brain, repetitive transcranial magnetic stimulation (rTMS) has the potential to modulate this specific region. Recent advances have enabled treatment technology to precisely target the left dorsolateral prefrontal cortex (DLPFC) and modify the functional connectivity (FC) between DLPFC and NAc in adolescent patients with anhedonia. Therefore, we plan to conduct a study to explore the safety and effectiveness of using resting-state functional connectivity magnetic resonance imaging (fcMRI)-guided rTMS to alleviate anhedonia in adolescents diagnosed with MDD.
METHODS: The aim of this article is to provide a study protocol for a parallel-group randomized, double-blind, placebo-controlled experiment. The study will involve 88 participants who will be randomly assigned to receive either active rTMS or sham rTMS. The primary object is to measure the percentage change in the severity of anhedonia, using the Snaith-Hamilton Pleasure Scale (SHAPS). The assessment will be conducted from the baseline to 8-week post-treatment period. The secondary outcome includes encompassing fMRI measurements, scores on the 17-item Hamilton Rating Scale for Depression (HAMD-17), the Montgomery Asberg Depression Rating Scale (MADRS), the Chinese Version of Temporal Experience of Pleasure Scale (CV-TEPS), and the Chinese Version of Beck Scale for Suicide Ideation (BSI-CV). The Clinical Global Impression (CGI) scores will also be taken into account, and adverse events will be monitored. These evaluations will be conducted at baseline, as well as at 1, 2, 4, and 8 weeks.
CONCLUSIONS: If the hypothesis of the current study is confirmed, (fcMRI)-guided rTMS could be a powerful tool to alleviate the core symptoms of MDD and provide essential data to explore the mechanism of anhedonia.
BACKGROUND: ClinicalTrials.gov NCT05544071. Registered on 16 September 2022.
METHODS: The aim of this article is to provide a study protocol for a parallel-group randomized, double-blind, placebo-controlled experiment. The study will involve 88 participants who will be randomly assigned to receive either active rTMS or sham rTMS. The primary object is to measure the percentage change in the severity of anhedonia, using the Snaith-Hamilton Pleasure Scale (SHAPS). The assessment will be conducted from the baseline to 8-week post-treatment period. The secondary outcome includes encompassing fMRI measurements, scores on the 17-item Hamilton Rating Scale for Depression (HAMD-17), the Montgomery Asberg Depression Rating Scale (MADRS), the Chinese Version of Temporal Experience of Pleasure Scale (CV-TEPS), and the Chinese Version of Beck Scale for Suicide Ideation (BSI-CV). The Clinical Global Impression (CGI) scores will also be taken into account, and adverse events will be monitored. These evaluations will be conducted at baseline, as well as at 1, 2, 4, and 8 weeks.
CONCLUSIONS: If the hypothesis of the current study is confirmed, (fcMRI)-guided rTMS could be a powerful tool to alleviate the core symptoms of MDD and provide essential data to explore the mechanism of anhedonia.
BACKGROUND: ClinicalTrials.gov NCT05544071. Registered on 16 September 2022.
摘要：
背景：Anhedonia，定义为无法感受到快乐，被认为是重度抑郁症（MDD）的核心症状。它可能会导致青少年的一些不良后果，包括加重的疾病严重程度,对抗抑郁药的抗性，MDD复发,甚至自杀。具体来说,患有快感缺乏的患者对选择性5-羟色胺再摄取抑制剂(SSRIs)和认知行为疗法(CBT)的反应可能有限.以前的研究揭示了快感缺失和奖励电路中的异常之间的联系，使伏隔核（NAc）成为潜在的治疗目标。然而,因为NAc在大脑深处，重复经颅磁刺激（rTMS）具有调节该特定区域的潜力。最近的进展使治疗技术能够精确地靶向左背外侧前额叶皮质（DLPFC），并改变青少年快感缺乏患者DLPFC和NAc之间的功能连接（FC）。因此,我们计划进行一项研究,以探讨使用静息态功能连接磁共振成像(fcMRI)引导的rTMS缓解青少年MDD患者快感缺失的安全性和有效性.
方法：本文的目的是为平行随机分组提供研究方案，双盲,安慰剂对照实验。该研究将涉及88名参与者，他们将被随机分配接受主动rTMS或假rTMS。主要目标是测量快感缺失严重程度的百分比变化，使用Snaith-Hamilton快乐量表（SHAPS）。评估将从基线到治疗后8周进行。次要结果包括fMRI测量，17项汉密尔顿抑郁量表（HAMD-17）的得分，蒙哥马利·阿斯伯格抑郁量表(MADRS)，中文版的时间体验快乐量表(CV-TEPS)，和中文版的贝克自杀意念量表（BSI-CV）。还将考虑临床总体印象（CGI）评分，和不良事件将被监测。这些评估将在基线进行，以及1、2、4和8周。
结论：如果本研究的假设得到证实，（fcMRI）指导的rTMS可能是缓解MDD核心症状的有力工具，并为探索快感缺失的机制提供必要的数据。
背景：ClinicalTrials.govNCT05544071。2022年9月16日注册。
方法：本文的目的是为平行随机分组提供研究方案，双盲,安慰剂对照实验。该研究将涉及88名参与者，他们将被随机分配接受主动rTMS或假rTMS。主要目标是测量快感缺失严重程度的百分比变化，使用Snaith-Hamilton快乐量表（SHAPS）。评估将从基线到治疗后8周进行。次要结果包括fMRI测量，17项汉密尔顿抑郁量表（HAMD-17）的得分，蒙哥马利·阿斯伯格抑郁量表(MADRS)，中文版的时间体验快乐量表(CV-TEPS)，和中文版的贝克自杀意念量表（BSI-CV）。还将考虑临床总体印象（CGI）评分，和不良事件将被监测。这些评估将在基线进行，以及1、2、4和8周。
结论：如果本研究的假设得到证实，（fcMRI）指导的rTMS可能是缓解MDD核心症状的有力工具，并为探索快感缺失的机制提供必要的数据。
背景：ClinicalTrials.govNCT05544071。2022年9月16日注册。
