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.
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。