Department of Pharmacology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Transl Psychiatry. 2021 Apr 27;11(1):249. doi: 10.1038/s41398-021-01364-0.
The Hamilton Depression Rating Scale (HDRS-17) measures symptoms that may overlap with common antidepressant side effects (e.g., sexual dysfunction), thus making it possible that side effects of antidepressant treatment are erroneously rated as symptoms of depression, and vice versa. This study uses patient-level data from previously conducted antidepressant treatment trials to assess whether side effect ratings co-vary with HDRS-17 ratings. Data from all HDRS-17-rated, industry-sponsored pre- and post-marketing trials (n = 4647) comparing the serotonin and noradrenaline reuptake inhibitor, duloxetine, to placebo and/or to a selective serotonin reuptake inhibitor were pooled; three studies, which utilised sub-therapeutic doses, did not have symptom-level ratings available and could not be included. Severity was assessed for side effects related to sleep, somatic anxiety, gastrointestinal function, and sexual dysfunction. Analysis of covariance was used to assess the relation between these side effects and ratings of relevant HDRS-17-derived outcome parameters. Side effects related to sleep, somatic anxiety and sexual dysfunction significantly and exclusively associated with higher scores on HDRS-17 items measuring the corresponding domains. Side effects related to gastrointestinal function associated with higher HDRS-17 item scores on all assessed domains. Treatment outcome was significantly related to side effect severity when assessed using HDRS-17-sum (beta 0.32 (0.074), p < 0.001), but not when the HDRS-6-sum-score (beta 0.035 (0.043), p = 0.415) or the depressed mood item (beta 0.007 (0.012), p = .527) were used as effect parameters. That some HDRS-17 items co-vary with common antidepressant side effects suggests some of these adverse events are counted twice, potentially leading to an underestimation of antidepressant efficacy.
汉密尔顿抑郁评定量表（HDRS-17）测量的症状可能与常见的抗抑郁药副作用重叠（例如性功能障碍），因此，抗抑郁药治疗的副作用可能被错误地评定为抑郁症状，反之亦然。本研究使用先前进行的抗抑郁治疗试验的患者水平数据来评估副作用评分是否与 HDRS-17 评分相关。对来自所有接受 HDRS-17 评定的、工业赞助的上市前和上市后试验（n=4647）的数据进行了汇总，这些试验比较了 5-羟色胺和去甲肾上腺素再摄取抑制剂度洛西汀与安慰剂和/或选择性 5-羟色胺再摄取抑制剂的疗效；三项使用亚治疗剂量的研究没有提供症状水平评分，因此无法纳入。评估了与睡眠、躯体焦虑、胃肠道功能和性功能障碍相关的副作用的严重程度。使用协方差分析来评估这些副作用与相关 HDRS-17 衍生结局参数评分之间的关系。与睡眠、躯体焦虑和性功能障碍相关的副作用与测量相应领域的 HDRS-17 项目的较高分数显著且唯一相关。与胃肠道功能相关的副作用与所有评估领域的 HDRS-17 项目得分较高相关。使用 HDRS-17 总分（beta 0.32（0.074），p<0.001）评估时，治疗结局与副作用严重程度显著相关，但使用 HDRS-6 总分评分（beta 0.035（0.043），p=0.415）或抑郁情绪项目（beta 0.007（0.012），p=0.527）作为效应参数时则不相关。一些 HDRS-17 项目与常见的抗抑郁药副作用相关，这表明其中一些不良事件被重复计算，可能导致抗抑郁药疗效被低估。
