Abstract | BACKGROUND: METHODS: This was an 8-week, multicenter, randomized, single-blind, active-controlled trial conducted at a psychiatric hospital (Beijing Anding Hospital) and a general hospital (Beijing Chaoyang Hospital) between April 2013 and September 2017. The primary outcome measure was improving depressive symptoms (Hamilton Depression Rating Scale (HAMD-24) score). The secondary outcomes included the change of HAMD-24 anxiety/somatization factor score and Clinical Global Impressions-Improvement (CGI-I) response rate. Safety was assessed by treatment-emergent adverse events (TEAEs) and laboratory tests. Efficacy was analyzed by using the full analysis set (FAS) following the modified intention-to-treat (mITT) principle. The primary endpoint measurements were analyzed using a mixed-effect model for repeated measures (MMRM) model with patients as a random-effect factor, treatment group as the independent variable, time as a repeated measure, and baseline covariates, using a first-order ante dependence covariance matrix. RESULTS: A total of 184 women were randomized. The full analysis set (FAS) included 172 patients ( venlafaxine, n = 82; fluoxetine, n = 90). Over the 8-week study period, the reduction in HAMD-24 scores was significant (P < 0.001) in both groups, while a significantly greater decline from baseline was observed in the venlafaxine group compared with the fluoxetine group (least-squares mean difference [95% CI]: - 2.22 [- 7.08, - 0.41]), P = 0.001). The baseline-to-week-8 least-squares mean change of the anxiety/somatization factor scores, CGI-I response rate were greater in the venlafaxine group than in the fluoxetine group (all P < 0.05). The most frequent TEAEs (≥5%) in both groups were nausea, somnolence, dizziness, headache, and dry mouth. There was no significant difference in the incidence of adverse events between the two groups. CONCLUSION:
Venlafaxine was well tolerated and compared to fluoxetine, it led to a greater improvement in the treatment of postmenopausal MDD. TRIAL REGISTRATION: Clinical Trials. gov #NCT01824433 . The trial was registered on April 4, 2013.
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Authors | Jingjing Zhou, Xiao Wang, Lei Feng, Le Xiao, Rui Yang, Xuequan Zhu, Hui Shi, Yongdong Hu, Runsen Chen, Philip Boyce, Gang Wang |
Journal | BMC psychiatry
(BMC Psychiatry)
Vol. 21
Issue 1
Pg. 260
(05 19 2021)
ISSN: 1471-244X [Electronic] England |
PMID | 34011310
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Cyclohexanols
- Serotonin Uptake Inhibitors
- Fluoxetine
- Venlafaxine Hydrochloride
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Topics |
- Cyclohexanols
- Depressive Disorder, Major
(drug therapy)
- Double-Blind Method
- Female
- Fluoxetine
(adverse effects)
- Humans
- Postmenopause
- Selective Serotonin Reuptake Inhibitors
(therapeutic use)
- Single-Blind Method
- Treatment Outcome
- Venlafaxine Hydrochloride
(adverse effects)
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