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Assays For Selecting A Treatment Regimen For A Subject With Depression And Methods For Treatment

A treatment plan and technology for depression, applied in biochemical equipment and methods, microbiological determination/testing, measuring devices, etc., can solve the problem that patients have no options

Inactive Publication Date: 2014-09-17
ALFASIGMA SPA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Despite significant advances in the treatment of depression over the past decade, as many as 29%-46% of depressed patients taking antidepressants remain partially or completely resistant to treatment
Those with treatment-resistant depression have few options

Method used

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  • Assays For Selecting A Treatment Regimen For A Subject With Depression And Methods For Treatment
  • Assays For Selecting A Treatment Regimen For A Subject With Depression And Methods For Treatment
  • Assays For Selecting A Treatment Regimen For A Subject With Depression And Methods For Treatment

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[1288] Example 1. Double-blind placebo-controlled study of folic acid-containing compounds in SSRI-resistant patients with major depressive disorder (MDD)

[1289] Exemplary Study Design

[1290] using a continuous parallel design [51] (see e.g., Figures 1A-1B and 2), a 60-day double-blind treatment of administering a folic acid-containing compound (eg, 6(S)-5-MTHF) or placebo as an SSRI adjuvant can be divided into two 30-day periods with assessments performed every 10 days. In the first phase of double-blind treatment, suitable patients can be randomized to 30 days of treatment with 6(S)-5-MTHF (15 mg / day) (n=19) or placebo (n=56), where treatment The random assignment ratios for sequential drug / drug (referring to 6(S)-5-MTHF), placebo / placebo, and placebo / drug were 2:3:3. For example only, if there is a 10% dropout rate in Phase 1, then 50 patients on placebo would complete Phase 1 of 30 days and 17 patients on 15 mg / day 6(S)-5-MTHF would complete The first phase. Patie...

Embodiment 2

[1358] Example 2 Evaluation of the efficacy of 6(S)-5-MTHF as a potentiation strategy in MDD patients (Trial 1)

[1359]A 60-day, multicenter, double-blind placebo of oral 6(S)-5-MTHF-enhancing efficacy of selective serotonin reuptake inhibitors (SSRIs) using the study design as described in the Examples and a serial parallel design A controlled study (Trial 1) has been completed in 148 patients with major depressive disorder (MDD) resistant to treatment with SSRIs. The study involved the enrollment of a total of 148 patients with MDD over 12 months across 10 medical centers or hospitals in the United States. Using a sequential parallel comparison design [51], outpatients with MDD were treated with 7.5 mg / day of 6(S)-5-MTHF or placebo as an adjuvant to SSRIs for 60 days. According to the continuous parallel design [51], the 60-day double-blind treatment was divided into two periods of 30 days each, with assessments performed every 10 days. like Figure 1A shown, during the ...

Embodiment 3

[1371] Example 3 Efficacy evaluation of 6(S)-5-MTHF as a potentiation strategy in MDD patients (trial 2)

[1372] Using the study design and serial parallel design as described in Example 1, this Example 3 shows selective serotonin resistance in 75 patients with major depressive disorder (MDD) resistant to treatment with SSRIs. A 60-day, multicenter, double-blind, placebo-controlled pilot study of the enhanced efficacy of oral 6(S)-5-MTHF at higher doses (15 mg qd) of resorptive inhibitors (SSRIs) (Trial 2). Design of Trial 2 (e.g. Figure 1B shown in) as in Trial 1, except for the dosing of 6(S)-5-MTHF, which was 15 mg / drug throughout the trial for those patients assigned to the placebo-drug and drug-drug groups sky.

[1373] The key clinical objective of the study was to determine whether higher doses of oral 6(S)-5-MTHF as an adjunct to SSRIs could be compared to placebo as an adjunct to SSRIs in outpatients with MDD who were partially responding or non-responding to SSRI...

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Abstract

Disclosed herein are novel assays, systems and kits for selecting a treatment regimen for a subject with depression by identifying at least one nucleic acid polymorphism, e.g., but not limited to, at the MTHFR, MTR, or MTRR locus, and / or determining expression levels of peripheral biomarkers (e.g., SAM, SAH, and 4-HNE) in a test sample from a human subject. These biomarkers can be used to determine the effectiveness of treating a depressed subject with a folate-containing compound (alone or as an adjunct to an antidepressant). Additionally, these biomarkers can be used to select an appropriate treatment regimen for subjects with treatment-resistant depression (e.g., resistant to at least one selective serotonin reuptake inhibitor). Methods and compositions for treating a subject with depression and / or determining or improving the effectiveness of an antidepressant drug taken by a subject are also provided herein.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS [0002] This application claims benefit under 35 U.S.C § 119(e) of US Provisional Application No. 61 / 559,541, filed November 14, 2011, the contents of which are incorporated herein by reference in its entirety. [0003] TECHNICAL FIELD OF THE DISCLOSURE [0004] Embodiments of the present invention generally relate to assays, methods and systems for selecting a treatment regimen for a subject suffering from depression (eg, major depressive disorder). The present invention further relates to methods for treating a subject suffering from depression (eg, major depressive disorder). Background of the Invention [0005] Recent estimates indicate that more than 19 million Americans over the age of 18 experience depression each year. It is generally believed that some form of link exists between folate deficiency states and depression [1, 2, and 3], which in turn helps explain earlier observations on various neuropsychiatric manifesta...

Claims

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Application Information

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IPC IPC(8): C12Q1/68G01N33/68
CPCC12Q2600/156C12Q2600/106G01N2800/52C12Q1/6883C12Q2600/158A61P25/24C12Q1/6813C12Q1/686C12Q1/68G01N33/68
Inventor M·法瓦G·帕帕科斯塔斯H·O·小科克D·克朗拉格
Owner ALFASIGMA SPA
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