期刊
INTERNATIONAL JOURNAL OF NEUROPSYCHOPHARMACOLOGY
卷 16, 期 2, 页码 313-321出版社
OXFORD UNIV PRESS
DOI: 10.1017/S1461145712000727
关键词
vortioxetine; multi-modal; randomized clinical trial
资金
- Takeda Pharmaceutical Company Ltd
- H. Lundbeck A/S
- AstraZeneca
- Forest
- Eli Lilly
- Pfizer
- Shire
- Takeda
- Agency for Healthcare Research and Quality
- GlaxoSmithKline
- National Institute of Mental Health
- Otsuka
- Sepracor
Vortioxetine (Lu AA21004) is a multi-modal antidepressant in clinical development for the treatment of major depressive disorder (MDD). The current study evaluated the efficacy and tolerability of 5 mg vortioxetine compared to placebo after 6 wk of treatment in adults with MDD in an out-patient setting. Adults aged 18-75 yr, with a diagnosis of MDD and a baseline Montgomery-Asberg Depression Rating Scale (MADRS) total score >= 30, were randomized to receive either 5 mg vortioxetine or placebo over 6 wk, followed by a 2-wk medication-free discontinuation period. The primary efficacy measure was change from baseline in Hamilton Rating Scale for Depression (HAMD)-24 total score at week 6 compared to placebo. Additional measures included response and remission rates, Clinical Global Impression Scale - Improvement scores, HAMD-24 total score in subjects with baseline Hamilton Anxiety Scale (HAMA) > 19 and MADRS-S total score. Adverse events (AEs) were assessed throughout the study. A total of 600 adults were randomized. There were no significant differences in efficacy measures between subjects in the 5 mg vortioxetine and placebo groups at week 6. HAMD-24 total score in subjects with baseline HAMA > 19 in the 5 mg vortioxetine group was improved at weeks 3-6 compared to the placebo group (nominal p value < 0.05). The most common AEs for the vortioxetine and placebo groups were nausea (19.1 and 9.4 %), headache (17.1 and 15.1%) and diarrhoea (11.4 and 7.0%), respectively. In this study of adults with MDD, 5 mg vortioxetine did not differ significantly from placebo in reducing depression symptoms after 6 wk of treatment.
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