Combined therapy for n-methyl-d-aspartic acid receptor antagonist-responsive neuropsychiatric disorders

A technology for neuropsychiatric diseases and glutamate receptors, applied in neurological diseases, active ingredients of hydroxyl compounds, drug combinations, etc., can solve problems such as increasing the risk of side effects

Pending Publication Date: 2020-04-10
格莱泰施有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Combinations of antidepressants have not been shown to be superior to monotherapy for treatment-resistant depression and often increase the risk of side effects and are not recommended

Method used

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  • Combined therapy for n-methyl-d-aspartic acid receptor antagonist-responsive neuropsychiatric disorders
  • Combined therapy for n-methyl-d-aspartic acid receptor antagonist-responsive neuropsychiatric disorders
  • Combined therapy for n-methyl-d-aspartic acid receptor antagonist-responsive neuropsychiatric disorders

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0137] Example 1: Demonstration of the hyperkinetic and antidepressant effects of D-cycloserine on rodents

[0138] For the present study, the psychomotor effects of D-cycloserine were assessed using rodent open field tests following D-cycloserine administration in the presence or absence of antidepressants.

[0139] All tests were performed at PsychoGenics Inc, 765 Old Saw Mill River Road, Tarrytown, NY 10591, USA.

[0140] Male C57BL / 6J mice (8 weeks old) from Jackson Laboratories (Bar Harbor, Maine) were used. Upon receipt, the mice were assigned a unique identification number (tail) and housed in OPT mouse cages in groups. All animals were acclimatized to the new colony room for 1 week prior to testing. During the acclimatization period, animals were regularly checked, handled and weighed to ensure adequate health and fitness. Animals were maintained on a 12 / 12 light / dark cycle. The room temperature is kept between 20 and 23°C, and the relative humidity is kept between...

Embodiment 2

[0167] Example 2: NMDAR Antagonists Alone and in Combination with Antidepressants and Effect of Antidepressants in the Rodent Forced Swim Test

[0168] For the present study, the antidepressant effects of NMDAR antagonists were assessed using the rodent forced swim test. NMDAR antagonists alone and in combination with specific antidepressants have been studied.

[0169] All tests were performed at PsychoGenics Inc, 765 Old Saw Mill River Road, Tarrytown, NY 10591, USA.

[0170] Male C57BL / 6J mice (8 weeks old) from Jackson Laboratories, Bar Harbor, ME were used. Upon receipt, the mice were assigned a unique identification number (tail) and housed in OPT mouse cages in groups. All animals were acclimatized to the new colony room for 1 week prior to testing. During the acclimatization period, animals were regularly checked, handled and weighed to ensure adequate health and fitness. Animals were maintained on a 12 / 12 light / dark cycle. The room temperature is kept between 20 ...

Embodiment 3

[0191] Example 3: Pharmacokinetics of DCS in Rodents

[0192]In the present study, the pharmacokinetics of D-cycloserine in rodents was evaluated. This study tested the hypothesis that the antidepressant effects of DCS in the above examples were specifically observed at therapeutic levels that produced sustained blood DCS levels >25 micrograms / mL.

[0193] In this study, male C57BL / 6J mice (8 weeks old) from Jackson Laboratories in Bar Harbor, Maine were used. DCS (30, 100, 300, 500 and 1000 mg / kg) was dissolved in PTS solvent (5% PEG200: 5% Tween 80: 90% NaCl) and administered by intraperitoneal injection at a dose of 10 mL / kg.

[0194] For each treatment group, a total of 12 mice were dosed: 4 mice were collected at 30, 60 and 120 minutes. Average plasma levels are calculated within 30-60 minutes.

[0195] Analysis of DCS in plasma was accomplished using a UPLC / MS / MS system consisting of an AcquityUPLC chromatography system from Waters and a Quattro Premier XE triple quad...

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Abstract

Described herein are compositions, including an oral dosage regimen, for the treatment of N-methyl-D-aspartic acid receptor-related neuropsychiatric disorders such as depression and obsessive-compulsive disorder and that includes an N-methyl-D-aspartic acid receptor antagonist, such as D-cycloserine formulated to produce plasma levels in excess of 25 microgram / mL, combined with more recently developed antidepressants.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of U.S. Provisional Application No. 62 / 510,801, filed May 25, 2017, and U.S. Provisional Application No. 62 / 518,020, filed June 12, 2017; It is incorporated herein by reference in its entirety. technical field [0003] Provided herein is an oral dosage regimen for the treatment of N-methyl-D-aspartate glutamate receptor (NMDAR)-associated neuropsychiatric disorders such as depression and obsessive-compulsive disorder, Among other treatments include NMDAR antagonists, such as D-cycloserine, formulated to produce plasma levels in excess of 25 micrograms per milliliter, in combination with recently developed antidepressants. Background technique [0004] Major depression is a clinical syndrome that includes persistent feelings of sadness or loss of interest in activities that persist for at least two weeks without treatment. Symptoms of major depression are usually measured using scal...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/42A61K31/55A61K31/06A61K31/135A61K31/495A61K31/381A61P25/24A61P25/00
CPCA61K31/4525A61K31/554A61K47/40A61P25/00A61K9/0019A61K31/135A61K31/4152A61K31/55A61K45/06A61P25/22A61P25/24A61K31/165A61K2300/00A61K31/42A61K31/405A61K31/496A61K31/495A61K9/0053
Inventor 丹尼尔·C·杰维特
Owner 格莱泰施有限责任公司
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