Randomized, 8-week, double-blind, placebo-controlled trial of vortioxetine in Japanese adults with major depressive disorder, followed by a 52-week open-label extension trial
| Autor: | Takeshi Inoue, Tadayuki Kitagawa, Kiyofumi Sasai, Akira Nishimura |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Vortioxetine
medicine.medical_specialty business.industry Nausea General Neuroscience Placebo-controlled study General Medicine medicine.disease Placebo 030227 psychiatry 03 medical and health sciences Psychiatry and Mental health 0302 clinical medicine Neurology Rating scale Internal medicine Clinical Global Impression medicine Major depressive disorder Neurology (clinical) medicine.symptom Adverse effect business 030217 neurology & neurosurgery |
| Zdroj: | Psychiatry and Clinical Neurosciences. 72:103-115 |
| ISSN: | 1323-1316 |
| DOI: | 10.1111/pcn.12623 |
| Popis: | Aim Safety and efficacy of vortioxetine (5-20 mg/day) in Japanese patients with major depressive disorder were evaluated in two phase 3 studies consisting of a short-term, 8-week, placebo-controlled, double-blind study followed by a long-term, 52-week, open-label extension study. Methods The primary end-point of the short-term study was change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at week 8. The primary objective of the extension study was vortioxetine's long-term safety; efficacy end-points included change in MADRS total score, Clinical Global Impression Scale (CGI)-Severity (S) score from the long-term study baseline, and CGI-Improvement (CGI-I) score over 52 weeks. Results Of the 366 randomized patients, 338 completed the short-term study, and 119 patients continued into the extension study. Primary (analysis of covariance) and secondary (mixed model for repeated measurements) analyses in the short-term study showed numerically greater, but not statistically significant, decreases in change in MADRS total score from baseline between the vortioxetine and placebo groups at week 8. In the long-term study, 86.6% of patients reported at least one treatment-emergent adverse event, with the most common being nasopharyngitis (40.3%) and nausea (21%). MADRS total score and CGI-I and CGI-S scores improved with continued vortioxetine treatment from baseline of the open-label study to week 52. Conclusion Vortioxetine failed to meet significance versus placebo in the primary efficacy analysis at week 8 in the short-term study. The extension trial indicated continued improvement of depressive symptoms from baseline of this study throughout the 52-week treatment period. Vortioxetine treatment was safe and well tolerated in both studies. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|