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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)

Exploratory Study of the Effects of Vortioxetine (Lu AA21004) on Cognition and Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Subjects Remitted From Depression and in Controls

Phase 1
Completed
Conditions
Depression
Interventions
First Posted Date
2012-05-28
Last Posted Date
2013-09-25
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
96
Registration Number
NCT01607125
Locations
🇬🇧

GB001, Headington, United Kingdom

Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2012-04-05
Last Posted Date
2014-10-13
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
437
Registration Number
NCT01571453

Efficacy of Lu AA21004 on Cognitive Dysfunction in Major Depressive Disorder

Phase 2
Completed
Conditions
Depressive Disorder, Major
Interventions
First Posted Date
2012-03-28
Last Posted Date
2015-02-05
Lead Sponsor
Takeda
Target Recruit Count
602
Registration Number
NCT01564862

Pharmacokinetics and Tolerability of Vortioxetine (Lu AA21004) in Child and Adolescent Patients With Depressive or Anxiety Disorder

Phase 2
Completed
Conditions
Depressive Disorder
Anxiety Disorder
Interventions
First Posted Date
2011-12-13
Last Posted Date
2017-03-16
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
48
Registration Number
NCT01491035
Locations
🇺🇸

US004, Wichita, Kansas, United States

🇺🇸

US002, Cincinnatti, Ohio, United States

🇺🇸

US003, Washington, District of Columbia, United States

and more 4 locations

A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2011-12-08
Last Posted Date
2014-03-26
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
495
Registration Number
NCT01488071

Efficacy Study of Vortioxetine on Cognitive Dysfunction in Adult Patients With Major Depressive Disorder

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2011-08-23
Last Posted Date
2014-08-05
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
598
Registration Number
NCT01422213

Vortioxetine (Lu AA21004) 10 and 20 mg for Treatment of Major Depressive Disorder With Sexual Dysfunction

Phase 3
Completed
Conditions
Treatment Outcome
Interventions
First Posted Date
2011-06-02
Last Posted Date
2014-10-09
Lead Sponsor
Takeda
Target Recruit Count
447
Registration Number
NCT01364649

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

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
Drug: Placebo
First Posted Date
2011-05-17
Last Posted Date
2014-11-11
Lead Sponsor
Takeda
Target Recruit Count
366
Registration Number
NCT01355081

Open-label Safety Extension Study of 15 and 20 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
2011-03-25
Last Posted Date
2014-02-11
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
71
Registration Number
NCT01323478

Effects of Vortioxetine (Lu AA21004) on the Concentrations of Selected Neurotransmitters in Healthy Male Adults

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Placebo
First Posted Date
2011-02-18
Last Posted Date
2013-12-13
Lead Sponsor
Takeda
Target Recruit Count
17
Registration Number
NCT01299805
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