Si Tianmei, Wang Gang, Yang Fude, Fang Yiru, Fang Maosheng, Li Jijun, Dong Jicheng, Shen Xinhua, Zhuo Jianmin, Rui Qing, Wang Jinan, Cuili Hu
National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital/ Institute of Mental Health) and the Key Laboratory of Mental Health, Ministry of Health (Peking University), Beijing, China.
Beijing Anding Hospital of Capital University of Medical Sciences, Beijing, China.
Metab Brain Dis. 2017 Jun;32(3):891-901. doi: 10.1007/s11011-017-9992-5. Epub 2017 Mar 15.
Severe depression accounts for one-third of depressed patients. Increasing severity of depression usually hinders patients from achieving remission. This study evaluated the efficacy and safety of escitalopram in acute-phase treatment of severe major depressive disorder (MDD). A total of 225 participants with severe MDD (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition criteria), with a current depressive episode and Montgomery-Asberg Depression Rating Scale (MADRS) score of ≥30 were enrolled. Participants received flexible dose escitalopram (10-20 mg/d) treatment for 8 weeks. Symptoms status was assessed by MADRS, Hamilton Depression Rating Scale (HAM-D-17), and Hamilton Anxiety Rating Scale (HAM-A). Quality of life was assessed by Short Form-12 (SF-12) and safety by adverse events, laboratory investigations, vital signs and physical findings. The remission (MADRS total score ≤ 10) rate in the intent-to-treat set (n = 207) was 72.9% at week 8. Significant improvement in symptoms compared to baseline, as evaluated by MADRS, HAMD-17 and HAMA scores at baseline, week 1, week 2, week 4, and week 8 (p < 0.0001 for all), was noted. Mean (SD) reduction from baseline in MADRS total score was 26.6 (11.38). Improvements in SF-12 score were significant (p = 0.000) and positively related to symptom improvement and negatively related to treatment-emergent adverse events (TEAEs). TEAEs were reported in 28.38% of participants. Most common TEAEs (>4%) were somnolence (9.0%), nausea (7.7%), hyperhidrosis (4.5%), dry mouth and dizziness (4.1% each). No serious TEAEs were reported. Escitalopram was effective and well-tolerated for acute-phase treatment of severe depression in Chinese population.
重度抑郁症患者占抑郁症患者总数的三分之一。抑郁症严重程度的增加通常会阻碍患者实现症状缓解。本研究评估了艾司西酞普兰在重度重度抑郁症（MDD）急性期治疗中的疗效和安全性。共纳入225例符合《精神疾病诊断与统计手册》第4版标准、目前处于抑郁发作且蒙哥马利-艾斯伯格抑郁量表（MADRS）评分≥30的重度MDD患者。参与者接受灵活剂量的艾司西酞普兰（10 - 20mg/d）治疗8周。通过MADRS、汉密尔顿抑郁量表（HAM-D-17）和汉密尔顿焦虑量表（HAM-A）评估症状状态。通过简明健康调查量表（SF-12）评估生活质量，通过不良事件、实验室检查、生命体征和体格检查评估安全性。在意向性治疗组（n = 207）中，第8周时的缓解率（MADRS总分≤10）为72.9%。与基线相比，在基线、第1周、第2周、第4周和第8周时通过MADRS、HAMD-17和HAMA评分评估的症状有显著改善（所有p < 0.0001）。MADRS总分较基线的平均（标准差）降低为26.6（11.38）。SF-12评分有显著改善（p = 0.000），且与症状改善呈正相关，与治疗中出现的不良事件（TEAE）呈负相关。28.38%的参与者报告了TEAE。最常见的TEAE（>4%）为嗜睡（9.0%）、恶心（7.7%）、多汗（4.5%）、口干和头晕（各4.1%）。未报告严重的TEAE。艾司西酞普兰在急性期治疗中国人群的重度抑郁症方面有效且耐受性良好。
