PMID- 22978748 OWN - NLM STAT- MEDLINE DCOM- 20130403 LR - 20181202 IS - 1473-4877 (Electronic) IS - 0300-7995 (Linking) VI - 28 IP - 10 DP - 2012 Oct TI - Vortioxetine (Lu AA21004) in the long-term open-label treatment of major depressive disorder. PG - 1717-24 LID - 10.1185/03007995.2012.725035 [doi] AB - OBJECTIVE: The primary objective of this study was to evaluate the safety and tolerability of the investigational drug vortioxetine (Lu AA21004) in the long-term treatment of patients with major depressive disorder. METHODS: Patients entered this 52-week, open-label extension study after completing an 8-week lead-in study. Safety and tolerability were evaluated at regular intervals on the basis of spontaneously reported adverse events (AEs), clinical safety laboratory tests, vital signs, ECG and physical examination. Effectiveness of treatment was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) total score. RESULTS: A total of 535 patients were treated and 61.3% (n = 328) completed the study, resulting in 393 patient years of exposure to vortioxetine. AEs reported by >/=10% of patients were nausea, headache, and nasopharyngitis. Taken together, six patients had eight AEs related to sexual dysfunction. There were no clinically significant safety findings with respect to mean changes of vital signs, weight, ECG parameters, or clinical laboratory values. Patients entered the extension study with a mean MADRS total score of 13.5 +/- 8.7. The mean MADRS total score decreased (improved) by approximately 8 points to 5.5 +/- 6.0 at Week 52 (OC). By the end of the study, the proportion of responders had increased from 63% to 94% (OC), as had the proportion in remission (MADRS /=22) of 9.7%. CONCLUSIONS: As with all open-label studies, the conclusions that can be drawn are limited by the lack of a placebo control, making it difficult to assess causality of any changes in outcome measures. However, on the basis of these findings, vortioxetine (2.5, 5, 10 mg/day) demonstrated a favourable safety and tolerability profile and maintained effectiveness over 12 months of treatment. TRIAL REGISTRATION: This study has the ClinicalTrials.gov identifier: NCT00694304. FAU - Baldwin, David S AU - Baldwin DS AD - Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, United Kingdom. dsb1@soton.ac.uk FAU - Hansen, Thomas AU - Hansen T FAU - Florea, Ioana AU - Florea I LA - eng SI - ClinicalTrials.gov/NCT00694304 PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20120917 PL - England TA - Curr Med Res Opin JT - Current medical research and opinion JID - 0351014 RN - 0 (Piperazines) RN - 0 (Sulfides) RN - 3O2K1S3WQV (Vortioxetine) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Depressive Disorder, Major/*drug therapy/physiopathology MH - Electrocardiography MH - Female MH - Headache/chemically induced/physiopathology MH - Humans MH - Longitudinal Studies MH - Male MH - Middle Aged MH - Nasopharyngitis/chemically induced/physiopathology MH - Nausea/chemically induced/physiopathology MH - Piperazines/*administration & dosage/*adverse effects MH - Sexual Dysfunction, Physiological/chemically induced/physiopathology MH - Sulfides/*administration & dosage/*adverse effects MH - Vortioxetine EDAT- 2012/09/18 06:00 MHDA- 2013/04/04 06:00 CRDT- 2012/09/18 06:00 PHST- 2012/09/18 06:00 [entrez] PHST- 2012/09/18 06:00 [pubmed] PHST- 2013/04/04 06:00 [medline] AID - 10.1185/03007995.2012.725035 [doi] PST - ppublish SO - Curr Med Res Opin. 2012 Oct;28(10):1717-24. doi: 10.1185/03007995.2012.725035. Epub 2012 Sep 17.