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Vortioxetine (Lu AA21004) in the long-term open-label treatment of major depressive disorder

Vortioxetine (Lu AA21004) in the long-term open-label treatment of major depressive disorder
Vortioxetine (Lu AA21004) in the long-term open-label treatment of major depressive disorder
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.
effectiveness, madrs, multimodal, remission, response, tolerability, vortioxetine
0300-7995
1717-1724
Baldwin, D.S.
1beaa192-0ef1-4914-897a-3a49fc2ed15e
Hansen, T.
76cd2d48-860b-49c9-be8b-54d6deea1252
Florea, I.
43033c2d-f714-48e8-b4c5-bb16a12f463f
Baldwin, D.S.
1beaa192-0ef1-4914-897a-3a49fc2ed15e
Hansen, T.
76cd2d48-860b-49c9-be8b-54d6deea1252
Florea, I.
43033c2d-f714-48e8-b4c5-bb16a12f463f

Baldwin, D.S., Hansen, T. and Florea, I. (2012) Vortioxetine (Lu AA21004) in the long-term open-label treatment of major depressive disorder. Current Medical Research and Opinion, 28 (10), 1717-1724. (doi:10.1185/03007995.2012.725035). (PMID:22978748)

Record type: Article

Abstract

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.

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More information

e-pub ahead of print date: 17 September 2012
Published date: October 2012
Keywords: effectiveness, madrs, multimodal, remission, response, tolerability, vortioxetine
Organisations: Faculty of Medicine

Identifiers

Local EPrints ID: 367943
URI: https://eprints.soton.ac.uk/id/eprint/367943
ISSN: 0300-7995
PURE UUID: b6cf3817-8076-4bae-aaa3-197d602c80bf

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Date deposited: 09 Sep 2014 13:33
Last modified: 18 Jul 2017 01:53

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Contributors

Author: D.S. Baldwin
Author: T. Hansen
Author: I. Florea

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