Sugawara Norio, Yasui-Furukori Norio, Tsuji Toshinaga, Hayashi Shinji, Ajisawa Yoshikazu, Ochiai Toshimitsu, Imagawa Hideyuki, Shimoda Kazutaka
Department of Psychiatry, Dokkyo Medical University School of Medicine, Tochigi, Japan.
Medical Affairs Department, Shionogi & Co., Ltd., Osaka, Japan.
Neuropsychiatr Dis Treat. 2020 Dec 11;16:3063-3070. doi: 10.2147/NDT.S274608. eCollection 2020.
The objective of this post hoc analysis was to explore the relationship, including changes over time, between baseline clinical symptom characteristics and working ability, judged by investigators, after 12 weeks of antidepressant monotherapy in Japanese patients with major depressive disorder (MDD) and painful physical symptoms (PPS) in a real-world clinical setting.
This prospective, observational study in patients treated with duloxetine or selective serotonin reuptake inhibitors was conducted from 2014 to 2016. Both treatment groups were pooled and divided into 2 groups, "working ability recovered" or "working ability not recovered," based on working ability at the end of the study. Patients were also divided into 4 subgroups by the presence or absence of previous depressive episodes and working ability. Main outcome measures included baseline demographics and clinical characteristics, and the 17-item Hamilton Rating Scale for Depression (HAM-D17).
Comparison between "working ability recovered" (n=122) and "working ability not recovered" (n=91) showed that the percentage of patients with complications and psychotherapy at baseline, and baseline HAM-D17 total, insomnia, somatic, and anxiety scores, were significantly different. The results of subgroup analyses were mostly the same as the results analyzed by working ability alone. Although statistical differences were observed for some outcome measures, the differences at baseline, except use of psychotherapy, may not be applicable clinically, and there were no specific trends observed that could predict working ability.
This post hoc analysis suggested that most baseline clinical characteristics, including the presence or absence of previous depressive episodes, were not predictive of working ability recovery. However, the use of psychotherapy in parallel with antidepressant monotherapy may be positively associated with working ability recovery. All outcome measures improved over time, reinforcing the importance of continuous treatment and observation to improve and accurately judge working ability in patients with MDD and PPS.
本事后分析的目的是在真实临床环境中,探讨日本重度抑郁症(MDD)伴疼痛性躯体症状(PPS)患者接受12周抗抑郁单药治疗后,基线临床症状特征与研究者判断的工作能力之间的关系,包括随时间的变化。
本前瞻性观察性研究于2014年至2016年对接受度洛西汀或选择性5-羟色胺再摄取抑制剂治疗的患者进行。两个治疗组合并后,根据研究结束时的工作能力分为“工作能力恢复”或“工作能力未恢复”两组。患者还根据既往是否有抑郁发作及工作能力分为4个亚组。主要结局指标包括基线人口统计学和临床特征,以及17项汉密尔顿抑郁评定量表(HAM-D17)。
“工作能力恢复”组(n = 122)与“工作能力未恢复”组(n = 91)的比较显示,基线时伴有并发症和接受心理治疗的患者百分比,以及基线HAM-D17总分、失眠、躯体和焦虑评分,存在显著差异。亚组分析结果与仅按工作能力分析的结果基本相同。虽然在一些结局指标上观察到统计学差异,但除心理治疗的使用外,基线时的差异在临床上可能不适用,且未观察到可预测工作能力的特定趋势。
本事后分析表明,大多数基线临床特征,包括既往是否有抑郁发作,均不能预测工作能力的恢复。然而,抗抑郁单药治疗同时使用心理治疗可能与工作能力恢复呈正相关。所有结局指标均随时间改善,这强化了持续治疗和观察对改善及准确判断MDD和PPS患者工作能力的重要性。