| WANG Ji-cai,LIU Fang,WANG Yan-jiao,LI Wen-yu,XU Xiu-feng,The second phase clinical trial of duloxetine enteric-coated tablets for the treatment of the maj or depressive disorder[J].SICHUAN MENTAL HEALTH,2014,27(2):132-136 |
| The second phase clinical trial of duloxetine enteric-coated tablets for the treatment of the maj or depressive disorder |
DOI：10.11886/scjsws201402012 |
| English keywords:Depressive disorder Duloxetine Enteric-coated Tablet Randomized controlled trials Double-blinded method Efficacy Safety |
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| Objective The aim of this study was to evaluate the efficacy and safety of duloxetine to the patients with depressive disorders.Methods a randomized,double-blind,double-dummy,parallel controlled study was carried out between 5 1 patients who met the DSM-Ⅳcriteria of depression and depressed episode.The 25 of total patients were treated with duloxetine（40～60 mg·d^-1）and the others were treated with paroxetine（20mg·d^-1 ）for 8 weeks.The efficacy were assessed by Hamilton Depression Rating Scale（HAMD）,Hamilton Anxiety Scale（HAMA）,Montgomery Depression Rating Scale（MADRS）,Sheehan Disability Scale（SDS）visual analogue scale（VAS-PI）、Clinical Global Impression （CGI）and the safety was assessed by Adverse Event .Results After 8 weeks treatment,the total effective rates of duloxetine group and paroxetine group were 72.0%and 73.1% respectively,with no significant difference（P〉0.05）.The clinical curing rate of duloxetine group and paroxetine group were 20.0% and 23.1% respectively,with no significant difference（P〉0.05）.The scores of HAMD17,HAMA, MADRS,SDS,VAS-PI and CGI in both groups decreased significantly,with statistically difference between the baseline and other observation time points（P〈0.001）.The adverse event rates of the duloxetine group and paroxetine group were 36.0%and 34.6% respectively,with no significant difference（P〉0.05）.The main adverse events of two groups were dry mouth, nausea,dizziness,Stomach discomfort,et al.Conclusion Duloxetine Enteric-coated Tablet as well as paroxetine is an effective antidepressants,with less side effects,better safety. |
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