Randomised Placebo-controlled Duloxetine-referenced Efficacy and Safety Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder
NCT ID: NCT00635219
Last Updated: 2014-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
766 participants
INTERVENTIONAL
2008-02-29
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
capsules; daily; orally
Vortioxetine: 2.5 mg
Vortioxetine (Lu AA21004)
2.5 mg/day; encapsulated tablets; orally
Vortioxetine: 5 mg
Vortioxetine (Lu AA21004)
5 mg/day; encapsulated tablets; orally
Vortioxetine: 10 mg
Vortioxetine (Lu AA21004)
10 mg/day; encapsulated tablets; orally
Duloxetine: 60 mg
Active reference
Duloxetine
60 mg/day; encapsulated capsules; orally
Interventions
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Placebo
capsules; daily; orally
Vortioxetine (Lu AA21004)
2.5 mg/day; encapsulated tablets; orally
Vortioxetine (Lu AA21004)
5 mg/day; encapsulated tablets; orally
Vortioxetine (Lu AA21004)
10 mg/day; encapsulated tablets; orally
Duloxetine
60 mg/day; encapsulated capsules; orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate to severe depression
* Current MDE duration of at least 3 months
Exclusion Criteria
* Any substance disorder within the previous 6 months
* Female patients of childbearing potential who are not using effective contraception
* Use of any psychoactive medication 2 weeks prior to screening and during the study
18 Years
75 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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References
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Baldwin DS, Loft H, Dragheim M. A randomised, double-blind, placebo controlled, duloxetine-referenced, fixed-dose study of three dosages of Lu AA21004 in acute treatment of major depressive disorder (MDD). Eur Neuropsychopharmacol. 2012 Jul;22(7):482-91. doi: 10.1016/j.euroneuro.2011.11.008. Epub 2011 Dec 30.
Belzeaux R, Gorgievski V, Fiori LM, Lopez JP, Grenier J, Lin R, Nagy C, Ibrahim EC, Gascon E, Courtet P, Richard-Devantoy S, Berlim M, Chachamovich E, Theroux JF, Dumas S, Giros B, Rotzinger S, Soares CN, Foster JA, Mechawar N, Tall GG, Tzavara ET, Kennedy SH, Turecki G. GPR56/ADGRG1 is associated with response to antidepressant treatment. Nat Commun. 2020 Apr 2;11(1):1635. doi: 10.1038/s41467-020-15423-5.
Christensen MC, Florea I, Loft H, McIntyre RS. Efficacy of vortioxetine in patients with major depressive disorder reporting childhood or recent trauma. J Affect Disord. 2020 Feb 15;263:258-266. doi: 10.1016/j.jad.2019.11.074. Epub 2019 Nov 13.
Belzeaux R, Fiori LM, Lopez JP, Boucekine M, Boyer L, Blier P, Farzan F, Frey BN, Giacobbe P, Lam RW, Leri F, MacQueen GM, Milev R, Muller DJ, Parikh SV, Rotzinger S, Soares CN, Uher R, Foster JA, Kennedy SH, Turecki G. Predicting Worsening Suicidal Ideation With Clinical Features and Peripheral Expression of Messenger RNA and MicroRNA During Antidepressant Treatment. J Clin Psychiatry. 2019 May 7;80(3):18m12556. doi: 10.4088/JCP.18m12556.
McIntyre RS, Florea I, Tonnoir B, Loft H, Lam RW, Christensen MC. Efficacy of Vortioxetine on Cognitive Functioning in Working Patients With Major Depressive Disorder. J Clin Psychiatry. 2017 Jan;78(1):115-121. doi: 10.4088/JCP.16m10744.
Other Identifiers
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EudraCT 2007-001870-95
Identifier Type: REGISTRY
Identifier Source: secondary_id
11984A
Identifier Type: -
Identifier Source: org_study_id
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