Document Detail


Vortioxetine (Lu AA21004) in the long-term open-label treatment of major depressive disorder.
MedLine Citation:
PMID:  22978748     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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-Åsberg 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 ≤10), increasing from 42% to 83% (OC). Patients in remission (n = 226) at the start of this study had a relapse rate (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.
Authors:
David S Baldwin; Thomas Hansen; Ioana Florea
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2012-09-17
Journal Detail:
Title:  Current medical research and opinion     Volume:  28     ISSN:  1473-4877     ISO Abbreviation:  Curr Med Res Opin     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-10-26     Completed Date:  2013-04-03     Revised Date:  2013-10-18    
Medline Journal Info:
Nlm Unique ID:  0351014     Medline TA:  Curr Med Res Opin     Country:  England    
Other Details:
Languages:  eng     Pagination:  1717-24     Citation Subset:  IM    
Affiliation:
Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, United Kingdom. dsb1@soton.ac.uk
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00694304
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Depressive Disorder, Major / drug therapy*,  physiopathology
Electrocardiography
Female
Headache / chemically induced,  physiopathology
Humans
Longitudinal Studies
Male
Middle Aged
Nasopharyngitis / chemically induced,  physiopathology
Nausea / chemically induced,  physiopathology
Piperazines / administration & dosage*,  adverse effects*
Sexual Dysfunction, Physiological / chemically induced,  physiopathology
Sulfides / administration & dosage*,  adverse effects*
Chemical
Reg. No./Substance:
0/Piperazines; 0/Sulfides; 3O2K1S3WQV/vortioxetine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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