Assays and methods for selecting a treatment regimen for a subject with depression

A depression and individual technology, applied in the direction of microbial determination/testing, biochemical equipment and methods, special data processing applications, etc.

Inactive Publication Date: 2016-04-20
NESTEC SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Although remarkable advances have been made in the treatment of depression over the past decade, as many as 29% to 46% of depressed patients taking antidepressants remain partially or completely resistant to treatment
Additionally, patients with treatment-resistant depression have few other options

Method used

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  • Assays and methods for selecting a treatment regimen for a subject with depression
  • Assays and methods for selecting a treatment regimen for a subject with depression
  • Assays and methods for selecting a treatment regimen for a subject with depression

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0543] Example 1. Identification of Biomarkers for Selecting Depressed Patients for Treatment with Folate-Containing Compounds in Combination with SSRIs

[0544] A double-blind, placebo-controlled study of 6(S)-5-MTHF in SSRI-resistant outpatients with major depressive disorder (MDD) to identify specific biomarker combinations that Greater efficacy response (e.g., a response greater than the additive response produced by the two SNPs, or greater than that produced by either SNP alone) when the patient is administered a folate-containing compound (e.g., 6(S)-5-MTHF) in addition to a depressant Responses to Responses) Correlation. See eg, Papakostas GI et al., Am J Psychiatry, 169:1267-74 (2012).

[0545] Multiple genetic biomarkers, one genetic biomarker, and clinical features were assessed for their impact on the efficacy of treatments containing folate-containing compounds (such as 6(S)-5-MTHF) and SSRIs in patients with depression. kind of combination. Specifically, the s...

Embodiment 2

[0556] Example 2. An Exemplary Method for Selecting Patients for Folate-Containing Boost Therapy (with SSRIs) and Individualized Prognosis of MDD Patients Undergoing Such Treatment

[0557] Based on the use of folate-containing compounds such as A double-blind, placebo-controlled, multi-site study of MDD treatment augmentation (in which 36 patients received folic acid-containing compounds such as ), whose HAMD-28 has a decrease from the baseline measurement), patients diagnosed with at least one of the conditions described in the test series (PT) (with corresponding "values" (as shown in detail later)) generally follow the following Expected HAMD-28 reduction responses shown in the table.

[0558] Accordingly, also provided herein are methods of treating a patient with MDD and / or determining or improving the effectiveness of antidepressants taken by a patient with MDD. For example, in some embodiments, the method may comprise (1) screening for treatment-resistant MDD patient...

Embodiment 3

[0571] Example 3. Effect of Adjunctive L-Methylfolate 15 mg in Depressed Patients Stratified by Biomarker Level and Genotype: Results from a Randomized Clinical Trial

[0572] This example illustrates methods for improving the effectiveness of antidepressants, such as selective serotonin reuptake inhibitors, administered to human patients diagnosed with or at risk of developing depression. The method comprises determining whether the patient carries at least one single nucleotide polymorphism (SNP), wherein the SNP is associated with an increased effectiveness of the antidepressant when administered in combination with a folate-containing compound (e.g., L-methylfolate) relevant. This embodiment also provides for use in the treatment of at least one symptom of depression (e.g., depressed mood, guilt, decreased work or interest, psychomotor retardation, agitation, psychogenic anxiety, physical anxiety, systemic symptoms, cognitive obstacles or any combination thereof). The me...

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Abstract

The present invention provides assays, methods and compositions for selecting a treatment regimen for a patient having depression or at risk for depression and/or treating at least one symptom of depression in the subject, based on the recognition that specific combinations of single nucleotide polymorphisms (SNPs) are associated with a therapeutic response to a folate-comprising compound. Provided herein are also methods for improving the effectiveness of an antidepressant drug administered to a subject with depression or at risk for depression by administering an adjunctive therapy of a folate-comprising compound to the subject if the subject carries a specific combination of SNPs that are predictive of a therapeutic response. Furthermore, provided herein are compositions of the folate-comprising compound.

Description

[0001] Cross References to Related Applications [0002] This application claims U.S. Patent Application No. 13 / 796,362, filed March 12, 2013, U.S. Provisional Application No. 61 / 777,650, filed March 12, 2013, and U.S. Provisional Application No. 61 / 914,338, filed December 10, 2013 The disclosures of these patent applications are hereby incorporated by reference in their entireties for all purposes. [0003] List references to attached "sequence listings," tables, or computer programs submitted as ASCII text files [0004] The Sequence Listing, written in the file SEQ_LISTING_95768-902165.TXT created on March 11, 2014, machine type IBM-PC, MS Windows operating system, is hereby incorporated by reference in its entirety for all purposes. Background technique [0005] Recent estimates suggest that more than 19 million Americans over the age of 18 experience depression each year. It is generally accepted that there is a correlation between folate deficiency status and depressio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G06F19/22
CPCC12Q1/6883C12Q2600/106C12Q2600/156A61P25/24
Inventor M·法瓦G·帕帕科斯塔斯H·O·小科克D·克朗拉格
Owner NESTEC SA
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