Safety and effectiveness of escitalopram in an 8-week open study in Chinese patients with depression and anxiety

Abstract

Background

Anxiety symptoms usually worsen depression and functional impairment. The present study was aimed to evaluate the impact of escitalopram on social function and quality of life in major depressive disorder (MDD) patients with anxiety symptoms.

Patients and methods

Adult MDD patients with functional impairment (Sheehan Disability Scale [SDS] score ≥9) and anxiety symptoms (Hamilton Anxiety Rating Scale [HAM-A] score ≥14) received escitalopram (10–20 mg/day) for 8 weeks. Symptom status was assessed by SDS, Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form, Montgomery-Åsberg Depression Rating Scale (MADRS), HAM-A, and Quick Inventory of Depressive Symptomatology-Self Report scales. Safety was evaluated by treatment-emergent adverse events (TEAEs).

Results

Overall, 208 (79.7%) of 261 enrolled patients completed the 8-week treatment. Mean (SD) SDS and Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form total scores were 17.4 (5.87) and 39.3 (14.43) at baseline, which improved to 7.6 (6.71) and 61.6 (15.80), respectively, at week 8. Totally, 59.2% of patients achieved functional remission (SDS≤6) and 61.7% of patients achieved depression remission (MADRS≤10) at week 8; 48.1% of patients achieved both functional and depression remission (SDS≤6 and MADRS≤10). The change in SDS total score was positively correlated with the change in MADRS and HAM-A total scores at each visit. Patient’s baseline SDS score was related with depression score (regression coefficient=0.40582, p=0.0005); remission of SDS was statistically related to a reduction of week 2 and week 6 HAM-A score (p<0.0001) and reduction of MADRS score (p<0.0001). Overall, 25.7% of patients reported ≥1 TEAEs. Most frequently reported TEAEs were nausea (5.8%), diarrhea (2.3%), and dizziness (2.7%). Most TEAEs were mild to moderate in severity. Four patients reported serious TEAEs, two patients reported suicide attempts, and one patient completed suicide.

Conclusion

Escitalopram (10–20 mg/day) treatment was efficacious in reducing depression, improving social function, and quality of life in MDD patients with anxiety symptoms. No new safety signals were identified.

Keywords:

• anxiety
• Chinese
• escitalopram
• major depressive disorder
• social function

Acknowledgments

The authors thank Dr Pan Jiyang for her role in enrolment of patients and conducting the study. The authors also thank the patients in this study, without whom the study would never have been accomplished. Writing assistance was provided by Dr Palash Kumar Das and additional editorial support was provided by Dr Rohit Bhandari (SIRO Clinpharm Pvt. Ltd., Thane, India), funded by Xi’an Janssen Pharmaceutical Ltd., China.

Author contributions

All authors contributed toward data analysis, drafting and revising the paper and agree to be accountable for all aspects of the work. The sponsor also provided a formal review of this manuscript. All authors met ICMJE criteria and all those who fulfilled those criteria are listed as authors. All authors had access to the study data and made the final decision about where to publish these data and approved submission to this journal.

Disclosure

The study presented in this report was sponsored by Xi’an Janssen Pharmaceutical Ltd. JW is an employee of Lundbeck Pharmaceutical Information Consulting Co., Ltd., China, JZ, and CH are employees of Xi’an Janssen Pharmaceutical Ltd., China. The authors report no other conflicts of interest in this work.