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Efficacy and Safety of Bupropion Hydrochloride Extended-Release Versus Escitalopram Oxalate in Chinese Patients With Major Depressive Disorder: Results From a Randomized, Double-Blind, Non-Inferiority Trial

Efficacy and Safety of Bupropion Hydrochloride Extended-Release Versus Escitalopram Oxalate in Chinese Patients With Major Depressive Disorder: Results From a Randomized, Double-Blind, Non-Inferiority Trial

Yifeng Shen, Qian Zhao, Yimin Yu, Yunlong Tan, Honggeng Zhang, Xiufeng Xu, Zhiyang Wang, Yan Li, Jingqiu Hu, Jinhua Zhong, Huafang Li

J Affect Disord. 2019 Oct 1;257:143-149.

PMID: 31301615

Abstract:

Background:
This study evaluated the non-inferiority of bupropion extended-release (XL) compared to escitalopram for acute-phase treatment of Chinese patients with major depressive disorder (MDD).
Methods:
This randomized (1:1), double-blind, active-control study conducted between February 2015 and October 2016 included patients with MDD (DSM-IV) (N = 538). The treatment phase had three dose levels (level 1 [Week 1], level 2 [Week 2-4], and level 3 [Week 5-8]), which included either bupropion XL 150 mg, 300 mg, 300 mg or escitalopram 10 mg, 10 mg, 10-20 mg (once-daily), respectively. Primary outcome was mean change from baseline in Hamilton Depression Rating Scale-17 (HAMD-17) total score at Week 8.
Results:
Overall, 534 patients (bupropion XL, n = 266; escitalopram, n = 268) received at least one dose of study medication. The least square mean (standard error) change from baseline in HAMD-17 total score at Week 8 was -14.5 (0.41) in bupropion XL group and -15.4 (0.39) in escitalopram group (mean difference: 0.8 [-0.27, 1.94]). The response rate was 69.6% versus 72.9%, remission rate was 39.7% versus 47.2%, sustained response rate was 51.6% versus 56.3%, and sustained remission rate was 25.5% versus 28.6%, respectively, for bupropion XL versus escitalopram group. Adverse events were reported by 313 patients (bupropion XL, n = 157; escitalopram, n = 156); the most common on-treatment adverse event in both groups was nausea (10.5% versus 18.7%, respectively).
Limitations:
A non-inferiority short-term (8 weeks) study without a placebo arm.
Conclusion:
Results from this study demonstrated that the efficacy of bupropion XL was non-inferior to that of escitalopram in Chinese patients with MDD.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP31677937-B	Bupropion Hydrochloride		31677-93-7	Price

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