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)

Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)

Phase 3
Completed
Conditions
Depressive Disorder, Major
Interventions
First Posted Date
2016-03-16
Last Posted Date
2022-09-22
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
683
Registration Number
NCT02709655
Locations
🇺🇸

Sun Valley Research Center, Imperial, California, United States

🇺🇸

Atlanta Center for Medical Research, Atlanta, Georgia, United States

🇺🇸

Northwest Behavioral Research Center, Marietta, Georgia, United States

and more 95 locations

Vortioxetine for MDD, Cognition, and Systemic Inflammatory Biomarkers

Phase 4
Withdrawn
Conditions
Unipolar Major Depression
Stage I, II or III Breast Cancer
Interventions
First Posted Date
2015-12-22
Last Posted Date
2016-09-30
Lead Sponsor
University of Miami
Registration Number
NCT02637466

Vortioxetine for Posttraumatic Stress Disorder

Phase 4
Completed
Conditions
Post-Traumatic Stress Disorder
Interventions
Drug: Placebo
First Posted Date
2015-12-22
Last Posted Date
2021-02-08
Lead Sponsor
University of Miami
Target Recruit Count
41
Registration Number
NCT02637895
Locations
🇺🇸

University of Miami, Miami, Florida, United States

🇺🇸

Emory University, Atlanta, Georgia, United States

Vortioxetine for Binge Eating Disorder

Phase 2
Completed
Conditions
Binge Eating Disorder
Interventions
Drug: Placebo
First Posted Date
2015-08-19
Last Posted Date
2020-11-23
Lead Sponsor
University of Chicago
Target Recruit Count
80
Registration Number
NCT02528409
Locations
🇺🇸

University of Chicago, Chicago, Illinois, United States

Vortioxetine in Patients With Major Depressive Disorder and Coronary Artery Disease

Early Phase 1
Withdrawn
Conditions
Coronary Artery Disease
Major Depressive Disorder
Interventions
First Posted Date
2015-05-27
Last Posted Date
2016-08-25
Lead Sponsor
Thomas Jefferson University
Registration Number
NCT02454426
Locations
🇺🇸

Thomas Jefferson University, Philadelphia, Pennsylvania, United States

A 10-Week, Open-Label, Flexible Dose Adaptive Study Evaluating the Efficacy of Vortioxetine in Subjects With Panic Disorder

Phase 4
Completed
Conditions
Panic Disorder
Interventions
First Posted Date
2015-03-23
Last Posted Date
2016-07-25
Lead Sponsor
Siyan Clinical Corporation
Target Recruit Count
27
Registration Number
NCT02395510
Locations
🇺🇸

Siyan Clinical Corporation, Santa Rosa, California, United States

A Phase 3 Study of Lu AA21004 in Patients With Major Depressive Disorder

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
Drug: Placebo
First Posted Date
2015-03-17
Last Posted Date
2021-03-24
Lead Sponsor
Takeda
Target Recruit Count
493
Registration Number
NCT02389816

Pharmacokinetic Properties of Vortioxetine in Healthy Young Chinese Men and Women

First Posted Date
2015-03-12
Last Posted Date
2015-05-19
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
64
Registration Number
NCT02386488
Locations
🇨🇳

CB801, Chengdu, China

Vortioxetine, 5, 10, and 20 mg, Relapse Prevention Study in Adults With Major Depressive Disorder (MDD)

Phase 4
Completed
Conditions
Major Depressive Disorder
Interventions
Drug: Placebo
First Posted Date
2015-02-26
Last Posted Date
2021-01-06
Lead Sponsor
Takeda
Target Recruit Count
1106
Registration Number
NCT02371980
Locations
🇺🇸

Atlanta Center for Medical Research, Atlanta, Georgia, United States

🇺🇸

Janice L. Miller, M.D., PA d/b/a Janus Center for Psychiatric Reseach, West Palm Beach, Florida, United States

🇺🇸

Collaborative Neuroscience Network, LLC, Torrance, California, United States

and more 71 locations

Adjunctive Vortioxetine in Schizophrenia

Phase 4
Active, not recruiting
Conditions
Schizophrenia
Negative Symptoms
Interventions
Other: Placebo
First Posted Date
2015-02-06
Last Posted Date
2024-02-08
Lead Sponsor
Northwell Health
Target Recruit Count
88
Registration Number
NCT02357797
Locations
🇺🇸

Cherry Health, Grand Rapids, Michigan, United States

🇺🇸

The Zucker Hillside Hospital, Glen Oaks, New York, United States

🇺🇸

Henderson Behavioral Health, Lauderdale Lakes, Florida, United States

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