抑郁症神经认知适应性训练联合 SSRIs 治疗晚年抑郁症患者认知障碍的有效性和安全性:一项为期 12 周的随机对照研究。

IF 3.4 2区 医学 Q2 PSYCHIATRY
Xiao Wang, Jiaojiao Zhou, Kemeng Zhu, Yida Wang, Xianglin Ma, Li Ren, Chengwei Guo, Zhanjun Zhang, Peng Lu, Qinge Zhang
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引用次数: 0

摘要

研究背景这项随机、开放标签研究考察了抑郁症神经认知适应训练(NCAT-D)联合选择性血清素再摄取抑制剂(SSRIs)对晚期抑郁症(LLD)患者认知障碍的治疗效果:研究数据收集于2021年5月5日至2023年4月21日。根据《精神疾病诊断与统计手册》第五版(DSM-5),符合重度抑郁障碍诊断标准的门诊患者(即汉密尔顿抑郁评定量表(HAMD-17)17项总分≥18分,蒙特利尔认知评估量表(MOCA)总分≥18分)结果:完整分析集(FAS)包括 118 名患者(NCAT-D 和 SSRIs 组,n = 57;SSRIs 和对照组,n = 61)。在为期12周的研究期间,MMRM分析显示,与SSRIs和对照组相比,NCAT-D和SSRIs组的认知功能(以ADAS-cog总分表示)从基线到治疗后的下降幅度明显更大[(F(1,115)= 13.65,最小二乘平均差[95% CI]:-2.77 [- 3.73, - 1.81],P 结论:NCAT-D和SSRIs组的认知功能下降幅度明显大于对照组:NCAT-D联合SSRIs对认知障碍的LLD患者有效且耐受性良好:试验注册:2022年10月18日注册于ClinicalTrials.gov Identifier:(#NCT05588102)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy and safety of Neurocognitive Adaptive Training for Depression combined with SSRIs for treating cognitive impairment among patients with late-life depression: a 12-week, randomized controlled study.

Background: This randomized, open-label study examined the therapeutic effects of Neurocognitive Adaptive Training for Depression (NCAT-D) combined with selective serotonin reuptake inhibitors (SSRIs) on cognitive impairment among patients with late-life depression (LLD).

Method: Study data were collected from May 5, 2021, to April 21, 2023. Outpatients who met the diagnostic criteria for major depressive disorder according to the fifth revision of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (i.e., a total score on the 17-item Hamilton Depression Rating Scale (HAMD-17) ≥ 18 and a total score on the Montreal Cognitive Assessment scale (MOCA) < 26) were recruited at Beijing Anding Hospital. These participants were randomly assigned to receive up to 12 weeks of NCAT-D and SSRIs treatment (n = 57) or SSRIs with a control treatment (n = 61). Primary outcomes included changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) scores from baseline to week 12 between the two groups. Assessments were conducted at baseline, after 2 weeks, 4 weeks, 8 weeks, and at 12 weeks. Mixed model repeated measures (MMRM) analysis was performed on modified intention-to-treat (mITT) and completer populations.

Results: The full analysis set (FAS) included 118 patients (NCAT-D and SSRIs group, n = 57; SSRIs and Control group, n = 61). During the 12-week study period, MMRM analysis revealed a significantly greater reduction in cognitive function (as indicated by ADAS-cog total scores) from baseline to post-treatment in the NCAT-D and SSRIs group compared to the SSRIs and Control groups [(F (1,115) = 13.65, least-squares mean difference [95% CI]: -2.77 [- 3.73, - 1.81], p < 0.001)]. The intervention group showed a significantly greater reduction in HAMD-17 scores compared to the control group [MMRM, estimated mean difference (SE) between groups: -3.59 [- 5.02, - 2.15], p < 0.001]. There was no significant difference in the incidence of adverse events between the two groups.

Conclusions: NCAT-D combined with SSRIs was efficacious and well tolerated in LLD patients with cognitive impairment.

Trial registration: Registered on October 18, 2022, at ClinicalTrials.gov Identifier: (#NCT05588102).

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来源期刊
BMC Psychiatry
BMC Psychiatry 医学-精神病学
CiteScore
5.90
自引率
4.50%
发文量
716
审稿时长
3-6 weeks
期刊介绍: BMC Psychiatry is an open access, peer-reviewed journal that considers articles on all aspects of the prevention, diagnosis and management of psychiatric disorders, as well as related molecular genetics, pathophysiology, and epidemiology.
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