Division of Psychiatry, Department of Molecular and Developmental Medicine, University of Siena School of Medicine, Italy.
H. Lundbeck A/S, Valby, Denmark.
J Affect Disord. 2021 Mar 15;283:472-479. doi: 10.1016/j.jad.2020.11.106. Epub 2020 Nov 19.
Inadequate treatment response and emotional blunting are common challenges with selective serotonin reuptake inhibitors/serotonin-noradrenaline reuptake inhibitors (SSRIs/SNRIs) for major depressive disorder (MDD). We investigated the effectiveness of vortioxetine on emotional blunting in patients with partial response to treatment with SSRIs/SNRIs.
Patients with MDD who experienced a partial response to SSRI/SNRI monotherapy at adequate dose for ≥6 weeks were switched to 8 weeks of vortioxetine treatment 10-20 mg/day (Study NCT03835715). Key inclusion criteria were Montgomery-Åsberg Depression Rating Scale (MADRS) total score >21 and <29, current major depressive episode <12 months, Oxford Depression Questionnaire (ODQ) total score ≥50, and confirmation of emotional blunting by standardized screening question. Emotional blunting was assessed by ODQ and depressive symptoms by MADRS. Other outcomes assessed included motivation and energy (Motivation and Energy Inventory [MEI]), cognitive performance (Digit Symbol Substitution Test [DSST]), and overall functioning (Sheehan Disability Scale [SDS]).
At week 8, patients (N=143) had improved by -29.8 points (p<0.0001) in ODQ total score; 50% reported no emotional blunting in response to standardized screening question. Significant improvements were observed on the DSST, MEI, and SDS at all time points assessed, and 47% of patients were in remission (MADRS total score ≤10) at week 8. The most common treatment-emergent adverse events included nausea, headache, dizziness, vomiting, and diarrhea.
No prospective phase before medication switch.
Vortioxetine 10-20 mg effectively improved emotional blunting, overall functioning, motivation and energy, cognitive performance, and depressive symptoms in patients with MDD with partial response to SSRI/SNRI therapy and emotional blunting.
选择性 5-羟色胺再摄取抑制剂/5-羟色胺-去甲肾上腺素再摄取抑制剂（SSRIs/SNRIs）治疗重度抑郁症（MDD）时，常会出现治疗反应不足和情绪迟钝。我们研究了文拉法辛在对 SSRIs/SNRIs 治疗部分反应的患者中情绪迟钝的疗效。
在适当剂量下接受 SSRI/SNRI 单药治疗≥6 周后对治疗部分反应的 MDD 患者转换为 8 周的文拉法辛治疗（剂量为 10-20mg/天；研究 NCT03835715）。主要纳入标准为：Montgomery-Åsberg 抑郁评定量表（MADRS）总分>21 且<29，当前的重度抑郁发作<12 个月，牛津抑郁问卷（ODQ）总分≥50，以及通过标准化筛查问题确认情绪迟钝。情绪迟钝通过 ODQ 进行评估，抑郁症状通过 MADRS 进行评估。评估的其他结果包括动力和精力（动力和精力量表[MEI]）、认知表现（数字符号替代测试[DSST]）和总体功能（Sheehan 残疾量表[SDS]）。
在第 8 周时，患者（N=143）ODQ 总分下降了-29.8 分（p<0.0001）；有 50%的患者对标准化筛查问题的反应无情绪迟钝。DSST、MEI 和 SDS 在所有评估时间点均有显著改善，并且 47%的患者在第 8 周时达到缓解（MADRS 总分≤10）。最常见的治疗相关不良事件包括恶心、头痛、头晕、呕吐和腹泻。
在药物转换前没有前瞻性阶段。
文拉法辛 10-20mg 可有效改善对 SSRIs/SNRIs 治疗有部分反应且有情绪迟钝的 MDD 患者的情绪迟钝、总体功能、动力和精力、认知表现和抑郁症状。
