title: Efficacy and safety of escitalopram in treatment of severe depression in Chinese population.
abstract: 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.
authors.affiliation: 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.
authors.forename: Tianmei
authors.initials: T
authors.lastname: Si
authors.affiliation: Beijing Anding Hospital of Capital University of Medical Sciences, Beijing, China.
authors.forename: Gang
authors.initials: G
authors.lastname: Wang
authors.affiliation: Beijing Huilongguan Hospital, Beijing, China.
authors.forename: Fude
authors.initials: F
authors.lastname: Yang
authors.affiliation: Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
authors.forename: Yiru
authors.initials: Y
authors.lastname: Fang
authors.affiliation: Wuhan Mental Hospital, Wuhan, China.
authors.forename: Maosheng
authors.initials: M
authors.lastname: Fang
authors.affiliation: Nanjing Brain Hospital, Jiangsu, China.
authors.forename: Jijun
authors.initials: J
authors.lastname: Li
authors.affiliation: Qingdao Mental Health Center, Qingdao, Shandong, China.
authors.forename: Jicheng
authors.initials: J
authors.lastname: Dong
authors.affiliation: The 3rd Hospital of Huzhou, Zhejiang, China.
authors.forename: Xinhua
authors.initials: X
authors.lastname: Shen
authors.affiliation: Xi'an Janssen Pharmaceutical Ltd, Beijing, China.
authors.forename: Jianmin
authors.initials: J
authors.lastname: Zhuo
authors.affiliation: Xi'an Janssen Pharmaceutical Ltd, Beijing, China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Rui
authors.affiliation: Xi'an Janssen Pharmaceutical Ltd, Beijing, China.
authors.forename: Jinan
authors.initials: J
authors.lastname: Wang
authors.affiliation: Xi'an Janssen Pharmaceutical Ltd, Beijing, China. chu9@its.jnj.com.|Therapeutic Area Physician, Medical Department, China R&D and Scientific Affairs, Xi'an Janssen Pharmaceutical Ltd., 19F, Tower 3, China Central Place, No. 77 Jian Guo Road, Chao Yang District, Beijing, 100025, China. chu9@its.jnj.com.
authors.forename: Hu
authors.initials: H
authors.lastname: Cuili
mesh_terms: D000328:Adult; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D044466:Asian People; D015283:Citalopram / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011159:Population Surveillance / Q000379:methods; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D018687:Antidepressive Agents, Second-Generation; D015283:Citalopram
keywords: Acute treatment; Chinese; Escitalopram; Major depressive disorder; Severe depression