Clinical trial of Morinda officinalis oligosaccharides in the continuation treatment of adults with mild and moderate depression
- VernacularTitle:巴戟天寡糖胶囊用于轻、中度抑郁症患者巩固期治疗的临床研究
- Author:
Shu-Zhe ZHOU
1
;
Zu-Cheng HAN
;
Xiu-Zhen WANG
;
Yan-Qing CHEN
;
Ya-Ling HU
;
Xue-Qin YU
;
Bin-Hong WANG
;
Guo-Zhen FAN
;
Hong SANG
;
Ying HAI
;
Zhi-Jie JIA
;
Zhan-Min WANG
;
Yan WEI
;
Jian-Guo ZHU
;
Xue-Qin SONG
;
Zhi-Dong LIU
;
Li KUANG
;
Hong-Ming WANG
;
Feng TIAN
;
Yu-Xin LI
;
Ling ZHANG
;
Hai LIN
;
Bin WU
;
Chao-Ying WANG
;
Chang LIU
;
Jia-Fan SUN
;
Shao-Xiao YAN
;
Jun LIU
;
Shou-Fu XIE
;
Mao-Sheng FANG
;
Wei-Feng MI
;
Hong-Yan ZHANG
Author Information
- Keywords: Morinda officinalis oligosaccharides; depression; efficacy; safety
- From: The Chinese Journal of Clinical Pharmacology 2024;40(6):815-819
- CountryChina
- Language:Chinese
- Abstract: Objective To observe the efficacy and safety of Morinda officinalis oligosaccharides in the continuation treatment of mild and moderate depression.Methods An open,single-arm,multi-center design was adopted in our study.Adult patients with mild and moderate depression who had received acute treatment of Morinda officinalis oligosaccharides were enrolled and continue to receive Morinda officinalis oligosaccharides capsules for 24 weeks,the dose remained unchanged during continuation treatment.The remission rate,recurrence rate,recurrence time,and the change from baseline to endpoint of Hamilton Depression Scale(HAMD),Hamilton Anxiety Scale(HAMA),Clinical Global Impression-Severity(CGI-S)and Arizona Sexual Experience Scale(ASEX)were evaluated.The incidence of treatment-related adverse events was reported.Results The scores of HAMD-17 at baseline and after treatment were 6.60±1.87 and 5.85±4.18,scores of HAMA were 6.36±3.02 and 4.93±3.09,scores of CGI-S were 1.49±0.56 and 1.29±0.81,scores of ASEX were 15.92±4.72 and 15.57±5.26,with significant difference(P＜0.05).After continuation treatment,the remission rate was 54.59％(202 cases/370 cases),and the recurrence rate was 6.49％(24 cases/370 cases),the recurrence time was(64.67±42.47)days.The incidence of treatment-related adverse events was 15.35％(64 cases/417 cases).Conclusion Morinda officinalis oligosaccharides capsules can be effectively used for the continuation treatment of mild and moderate depression,and are well tolerated and safe.
