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Efficacy and safety of escitalopram in treatment of severe depression in Chinese population

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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.

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Acknowledgements

We acknowledge Dr. Himabindu Gutha for providing writing assistance and Dr. Madhavi Patil (both SIRO Clinpharm Pvt. Ltd., India) for additional editorial support for the development of this manuscript. The authors also thank the study participants, without whom the study would never have been accomplished.

Dr. Si Tianmei was the principal investigator of the study and Drs. Wang Jinan, Rui Qing and Hu Cuili were the clinical pharmacology scientists, contributing to protocol writing, data analysis and interpretation. Dr. Zhuo Jianmin was the study statistician and had primary role in the statistical analyses and data interpretation. All other authors contributed to the study design and implementation, data interpretation as well as development and review of manuscript.

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Authors and Affiliations

  1. 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

    Tianmei Si

  2. Beijing Anding Hospital of Capital University of Medical Sciences, Beijing, China

    Gang Wang

  3. Beijing Huilongguan Hospital, Beijing, China

    Fude Yang

  4. Division of Mood Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China

    Yiru Fang

  5. Wuhan Mental Hospital, Wuhan, China

    Maosheng Fang

  6. Nanjing Brain Hospital, Jiangsu, China

    Jijun Li

  7. Qingdao Mental Health Center, Qingdao, Shandong, China

    Jicheng Dong

  8. The 3rd Hospital of Huzhou, Zhejiang, China

    Xinhua Shen

  9. Xi’an Janssen Pharmaceutical Ltd, Beijing, China

    Jianmin Zhuo, Qing Rui, Jinan Wang & Hu Cuili

  10. 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

    Hu Cuili

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  1. Tianmei Si
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  12. Hu Cuili
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Correspondence to Hu Cuili.

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Funding

The study presented in this report is supported by Xi’an Janssen Pharmaceutical Ltd. Beijing, China.

Conflict of interest

Drs. Zhuo, Rui, Wang and Hu are employees of Xi’an Janssen Pharmaceutical Ltd. Beijing, China. They do not hold stocks in the company. All the other authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in the study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Si, T., Wang, G., Yang, F. et al. Efficacy and safety of escitalopram in treatment of severe depression in Chinese population. Metab Brain Dis 32, 891–901 (2017). https://doi.org/10.1007/s11011-017-9992-5

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