TY - JOUR
T1 - Bupropion SR and fluoxetine in treatment of depression in multicenter clinical trial
AU - Ma, Xiancang
AU - Gao, Chengge
AU - Tan, Qingrong
AU - Xu, Xiufeng
AU - Chu, Zhaohu
AU - Zhang, Minglian
AU - Yu, Hao
PY - 2007/10
Y1 - 2007/10
N2 - Objective: To evaluate the efficacy and safety of bupropion hydrochloride tablet in the treatment of depression. Methods: A randomized, double-blinded, double-dummy fluoxetine controlled, multicenter clinical trial was conducted. The primary efficacy indicator was the decreased score of Hamilton Depression (HAMD) Rating Scale 17; treatment emergent symptom scale, laboratory examinations, ECG, vital signs and physical examinations were used to evaluate safety of the medicine. Results: Totally 228 treated patients were enrolled in this trial. Among them, the per protocol (PP) sample was 208 patients. Based on the PP sample, the HAMD 17 decreased score of bupropion group was (14.27 ± 6.21) six weeks after treatment, while fluoxetine group was (14.8 6± 6.09), and there were no significant differences between the two groups (P > 0.05). Besides, there were no significant differences in response rate (P > 0.05), remission rate (P > 0.05), CGI and HAMA. Safety analysis showed no significant differences found in symptoms and frequency of side effects between the two groups. Conclusion: Bupropion SR tablet is an effective and safe antidepressant. It has a similar effect and safety compared with fluoxetine in treatment of depression.
AB - Objective: To evaluate the efficacy and safety of bupropion hydrochloride tablet in the treatment of depression. Methods: A randomized, double-blinded, double-dummy fluoxetine controlled, multicenter clinical trial was conducted. The primary efficacy indicator was the decreased score of Hamilton Depression (HAMD) Rating Scale 17; treatment emergent symptom scale, laboratory examinations, ECG, vital signs and physical examinations were used to evaluate safety of the medicine. Results: Totally 228 treated patients were enrolled in this trial. Among them, the per protocol (PP) sample was 208 patients. Based on the PP sample, the HAMD 17 decreased score of bupropion group was (14.27 ± 6.21) six weeks after treatment, while fluoxetine group was (14.8 6± 6.09), and there were no significant differences between the two groups (P > 0.05). Besides, there were no significant differences in response rate (P > 0.05), remission rate (P > 0.05), CGI and HAMA. Safety analysis showed no significant differences found in symptoms and frequency of side effects between the two groups. Conclusion: Bupropion SR tablet is an effective and safe antidepressant. It has a similar effect and safety compared with fluoxetine in treatment of depression.
KW - Bupropion SR tablet
KW - Depression
KW - Efficacy
KW - Fluoxetine
KW - Safety
UR - https://www.scopus.com/pages/publications/36048988776
M3 - 文章
AN - SCOPUS:36048988776
SN - 1671-8259
VL - 28
SP - 533-536+543
JO - Journal of Xi'an Jiaotong University (Medical Sciences)
JF - Journal of Xi'an Jiaotong University (Medical Sciences)
IS - 5
ER -