Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Methods of treating depression with vortioxetine

Inactive Publication Date: 2019-07-18
RUNDLE RES LLC
View PDF0 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent text describes the discovery that some patients may have a higher risk of experiencing harmful side effects when taking vortioxetine, a medication commonly used to treat depression. These patients may need longer periods of time to fully detox from vortioxetine before starting another medication to treat their condition. The patent aims to help healthcare professionals identify these patients and take appropriate measures to protect them from these potential risks.

Problems solved by technology

However, when using vortioxetine, switching a patient to an MAOI may elevate the serotonin levels too much and may greatly increase the patient's risks of developing serotonin syndrome, or serotonin toxicity, for which there is no antidote, and which can be life threatening or fatal if not monitored carefully.
In some cases, the risks of transitioning from treatment with vortioxetine to an MAOI may be perceived as so severe that a physician may not even attempt treatment with vortioxetine in case a transition to treatment with an MAOI may be required.
However, this recommendation presumes that every patient requires the same washout period and may overlook that certain patient populations may require different washout periods when transitioning from vortioxetine to an MAOI.

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Methods of treating depression with vortioxetine
  • Methods of treating depression with vortioxetine
  • Methods of treating depression with vortioxetine

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0157]To test if the obese patients would require different washout guidelines for preventing serotonin syndrome, 16 obese subjects (BMI ≥35) and 13 normal subjects (BMI <25) completed a clinical trial where they were administered daily with low doses (5 mg / day) of vortioxetine for 29 days in a controlled study. All subjects were subsequently tracked for 28 days after discontinuing vortioxetine on day 29. Blood samples were collected and processed according to standard techniques.

[0158]The weight, BMI, waist measurement, % body weight, % total fat, % android fat, % gynoid fat, total fat, metabolizer status, and measured half-life of each subject in shown in Table 1, below.

TABLE 1Vortioxetine Half-Life and Subject Characteristics%%%TotalT1 / 2CssWeightBMIWaist%TotalAndroidGynoidFatMetab.Subject(h)(ng / mL)(kg)(kg / m2)(in)IBWFatFatFat(kg)StatusCohort01_00863.95.4263.022.630.7107.738.238.140.524.1EMNormal01_00952.84.1462.721.731.5102.339.140.442.924.5EMNormal01_01050.73.1362.223.631.5105.42...

example 2

[0164]Data obtained in the study described in Example 1 and Table 1 provided the basis for a regression model (having a r2 value of 88%) based on total body fat and steady-state vortioxetine plasma concentration. Because the steady-state plasma concentration of vortioxetine correlates with metabolizer status, this regression provides a means of estimating vortioxetine half-life for patients based on total body fat and CYP2D6 metabolizer status. The results are shown in Table 4.

TABLE 4Half-Life Estimates (hrs) Based on Total Body Fat (kg) and Metabolizer StatusTotal Fat (Kg)102030405060708090100MetabolizerExtensive(a)2132425262738393103114StatusExtensive(b)394959708090100111121131IM(c)102112123133143153164174184194IM(d)116126136147157167177188198208PM(e)215225235245256266276286297307(a)average of obese steady-state concentration for extensive metabolizers(b)high of extensive metabolizers(c)average of intermediate metabolizer (IM) values(d)high of IM values(e)estimated poor metabolize...

example 3

[0167]The clinical trials in Examples 1 and 2 are discussed in more detail below.

Overall Design

[0168]The normal-weight control group consisted of healthy male and female volunteers aged 18 to 45 years. Their body mass index (BMI) values fell in the range of 18.5 to 25 kg / m2. The overweight subjects had a BMI of at least 35 kg / m2. Normal weight and obese subjects were matched as closely as possible for gender and age.

[0169]Potential study participants underwent screening and evaluation within 30 days of study initiation. Procedures included: medical and psychiatric history, physical examination, electrocardiogram if indicated, hematologic and biochemical screening, and urine testing for drugs of abuse. All study participants were healthy active non-smoking adults with no history of significant medical or psychiatric disease, and taking no prescription medications. Overweight subjects were free of metabolic or other complications of obesity. Potentially child-bearing women in both gro...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
Weightaaaaaaaaaa
Weightaaaaaaaaaa
Fractionaaaaaaaaaa
Login to View More

Abstract

The present disclosure relates to methods of transitioning patients or obese patients being treated with vortioxetine to treatment with a monoamine oxidase inhibitor (MAOI). The methods provided include delaying administration of the MAOI for certain time periods after stopping administration of vortioxetine. The patients or obese patients possess various capabilities of metabolizing vortioxetine. The current disclosure also includes methods of switching patients to a MAOI intended to treat psychiatric disorders while being treated with vortioxetine. The methods disclosed further comprise determining vortioxetine plasma clearance and washout time for patients with different body fat status and / or different CYP2D6 metabolizer status.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation-in-part application of U.S. patent application Ser. No. 15 / 838,944, filed Dec. 12, 2017, which is a continuation-in-part application of U.S. patent application Ser. No. 15 / 474,675, filed on Mar. 30, 2017, the disclosure of each of which is hereby incorporated by reference in its entirety for all purposes.BACKGROUND[0002]Serotonergic antidepressants, including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), are drugs that are used for treating various depression and anxiety related disorders. Vortioxetine, also called Brintellix or Trintellix, is a serotonergic antidepressant that is used for treating major depressive disorders, and has been characterized as an SSRI which also acts as a 5HT agonist, antagonist, and transport inhibitor. Vortioxetine can function as a serotonin modulator and stimulator, which can antagonize postsynaptic serotonin rec...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
IPC IPC(8): A61K31/495A61K45/06A61P25/24
CPCA61P25/24A61K31/495A61K45/06
Inventor SRINIVASAN, SUNDARCHOW, CHRISTINA
Owner RUNDLE RES LLC
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com