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 and Safety Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder

Phase 2
Completed
Conditions
Depressive Disorder, Major
Interventions
Drug: Placebo
First Posted Date
2010-12-07
Last Posted Date
2013-12-18
Lead Sponsor
Takeda
Target Recruit Count
600
Registration Number
NCT01255787

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

Phase 3
Completed
Conditions
Depressive Disorder, Major
Interventions
Drug: Placebo
First Posted Date
2010-08-11
Last Posted Date
2013-12-18
Lead Sponsor
Takeda
Target Recruit Count
469
Registration Number
NCT01179516

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

Phase 3
Completed
Conditions
Depressive Disorder, Major
Interventions
Drug: Placebo
First Posted Date
2010-07-15
Last Posted Date
2013-12-18
Lead Sponsor
Takeda
Target Recruit Count
462
Registration Number
NCT01163266

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

Phase 3
Completed
Conditions
Depressive Disorder, Major
Interventions
First Posted Date
2010-06-29
Last Posted Date
2013-12-18
Lead Sponsor
Takeda
Target Recruit Count
614
Registration Number
NCT01153009

Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study

Phase 3
Completed
Conditions
Depressive Disorder, Major
Interventions
First Posted Date
2010-06-29
Last Posted Date
2014-05-28
Lead Sponsor
Takeda
Target Recruit Count
1075
Registration Number
NCT01152996

Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 15 and 20 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2010-06-10
Last Posted Date
2014-02-11
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
607
Registration Number
NCT01140906

Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults

Phase 2
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2009-02-09
Last Posted Date
2014-05-13
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
426
Registration Number
NCT00839423

Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 5 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Elderly Patients

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2008-12-18
Last Posted Date
2014-01-29
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
453
Registration Number
NCT00811252

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

Phase 2
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2008-09-29
Last Posted Date
2014-01-29
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
74
Registration Number
NCT00761306

Efficacy and Safety of Vortioxetine (Lu AA21004) for Treatment of Generalized Anxiety Disorder in Adults.

Phase 3
Completed
Conditions
Generalized Anxiety Disorder
Interventions
Drug: Placebo
First Posted Date
2008-09-01
Last Posted Date
2014-03-03
Lead Sponsor
Takeda
Target Recruit Count
301
Registration Number
NCT00744627
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