MedPath

Vortioxetine

Generic Name
Vortioxetine
Brand Names
Brintellix, Trintellix
Drug Type
Small Molecule
Chemical Formula
C18H22N2S
CAS Number
508233-74-7
Unique Ingredient Identifier
3O2K1S3WQV
Background

Vortioxetine is an antidepressant medication indicated for the treatment of major depressive disorder (MDD). It is classified as a serotonin modulator and stimulator (SMS) as it has a multimodal mechanism of action towards the serotonin neurotransmitter system whereby it simultaneously modulates one or more serotonin receptors and inhibits the reuptake of serotonin. More specifically, vortioxetine acts via the following biological mechanisms: as a serotonin reuptake inhibitor (SRI) through inhibition of the serotonin transporter, as a partial agonist of the 5-HT1B receptor, an agonist of 5-HT1A, and an antagonist of the 5-HT3, 5-HT1D, and 5-HT7 receptors. SMSs were developed because there are many different subtypes of serotonin receptors, however, not all of these receptors appear to be involved in the antidepressant effects of SRIs. Some serotonin receptors seem to play a relatively neutral or insignificant role in the regulation of mood, but others, such as 5-HT1A autoreceptors and 5-HT7 receptors, appear to play an oppositional role in the efficacy of SRIs in treating depression.

Indication

用于治疗重度抑郁症成人患者。

Associated Conditions
Major Depressive Disorder (MDD)

Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
Drug: Placebo
First Posted Date
2008-08-15
Last Posted Date
2013-12-18
Lead Sponsor
Takeda
Target Recruit Count
560
Registration Number
NCT00735709

An Efficacy and Safety Study of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

Phase 3
Completed
Conditions
Generalized Anxiety Disorder
Interventions
Drug: Placebo
First Posted Date
2008-08-13
Last Posted Date
2013-12-18
Lead Sponsor
Takeda
Target Recruit Count
304
Registration Number
NCT00734071

Study of Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

Phase 3
Completed
Conditions
Generalized Anxiety Disorder
Interventions
Drug: Placebo
First Posted Date
2008-08-08
Last Posted Date
2013-12-18
Lead Sponsor
Takeda
Target Recruit Count
457
Registration Number
NCT00731120

Efficacy of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

Phase 3
Completed
Conditions
Generalized Anxiety Disorder
Interventions
First Posted Date
2008-08-08
Last Posted Date
2013-12-18
Lead Sponsor
Takeda
Target Recruit Count
781
Registration Number
NCT00730691

Safety and Tolerability of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2008-07-02
Last Posted Date
2013-12-13
Lead Sponsor
Takeda
Target Recruit Count
836
Registration Number
NCT00707980

Open-label Safety Extension Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2008-06-10
Last Posted Date
2014-04-01
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
535
Registration Number
NCT00694304

Efficacy and Safety of Vortioxetine (Lu AA21004) in the Treatment of Patients With Major Depressive Disorder

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2008-05-06
Last Posted Date
2013-12-18
Lead Sponsor
Takeda
Target Recruit Count
611
Registration Number
NCT00672620

Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Adults With Major Depressive Disorder

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
Drug: Placebo
First Posted Date
2008-05-06
Last Posted Date
2013-12-13
Lead Sponsor
Takeda
Target Recruit Count
600
Registration Number
NCT00672958

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

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2008-03-13
Last Posted Date
2014-02-11
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
766
Registration Number
NCT00635219

Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2008-01-17
Last Posted Date
2014-03-31
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
639
Registration Number
NCT00596817
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