BIOMARKERS FOR MONITORING TREATMENT OF NEUROPSYCHIATRIC DISEASES
First Claim
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1. A method for identifying biomarkers of neuropsychiatric disease, comprising:
- (a) calculating a first diagnostic disease score for a subject having said neuropsychiatric disease, wherein said first diagnostic disease score is calculated prior to administration of vagus nerve stimulation to said subject;
(b) providing numerical values for the levels of one or more analytes in a first biological sample obtained from said subject prior to administration of said vagus nerve stimulation;
(c) calculating a second diagnostic disease score for said subject after administration of said vagus nerve stimulation;
(d) providing numerical values for the levels of said one or more analytes in a second biological sample obtained from said subject after administration of said vagus nerve stimulation; and
(e) identifying one or more analytes as being biomarkers for said neuropsychiatric disease, wherein said one or more analytes are identified as biomarkers if they are differentially expressed between said first and second biological samples, wherein said differential expression of said one or more analytes correlates to a positive or negative change in said subject'"'"'s diagnostic score.
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Abstract
Methods for identifying and measuring pharmacodynamic biomarkers of neuropsychiatric disease, and for monitoring a subject'"'"'s response to treatment. For example, materials and methods for monitoring the effectiveness of vagus nerve stimulation in a subject having a neuropsychiatric disease are provided.
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Citations
22 Claims
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1. A method for identifying biomarkers of neuropsychiatric disease, comprising:
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(a) calculating a first diagnostic disease score for a subject having said neuropsychiatric disease, wherein said first diagnostic disease score is calculated prior to administration of vagus nerve stimulation to said subject; (b) providing numerical values for the levels of one or more analytes in a first biological sample obtained from said subject prior to administration of said vagus nerve stimulation; (c) calculating a second diagnostic disease score for said subject after administration of said vagus nerve stimulation; (d) providing numerical values for the levels of said one or more analytes in a second biological sample obtained from said subject after administration of said vagus nerve stimulation; and (e) identifying one or more analytes as being biomarkers for said neuropsychiatric disease, wherein said one or more analytes are identified as biomarkers if they are differentially expressed between said first and second biological samples, wherein said differential expression of said one or more analytes correlates to a positive or negative change in said subject'"'"'s diagnostic score. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A method for identifying biomarkers of neuropsychiatric disease, comprising:
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(a) providing a first biological sample from a subject; (b) determining said subject'"'"'s first diagnostic disease score; (c) administering vagus nerve stimulation to said subject; (d) providing a second biological sample from said subject obtained following vagus nerve stimulation, and determining expression of one or more analytes in said first biological sample and said second biological sample; (e) determining said subject'"'"'s second diagnostic disease score following the vagus nerve stimulation; and (f) identifying one or more analytes as being biomarkers for said neuropsychiatric disease, wherein said one or more analytes are identified as biomarkers if they are differentially expressed between said first and second biological samples, wherein said differential expression of said one or more analytes correlates to a positive or negative change in said subject'"'"'s diagnostic score.
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17. A method for assessing a treatment response in a mammal having a neuropsychiatric disease, comprising:
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(a) determining a first diagnostic disease score for said mammal, wherein said first diagnostic disease score is calculated using numerical values for the levels of at least two inflammatory markers, at least two HPA axis markers, and at least two metabolic markers present in a first biological sample obtained from said mammal prior to administration of said treatment; (b) determining a second diagnostic disease score for said mammal, wherein said second diagnostic disease score is calculated using numerical values for the levels of at least two inflammatory markers, at least two HPA axis markers, and at least two metabolic markers present in a second biological sample obtained from said mammal after administration of said treatment; and (c) maintaining, adjusting, or stopping said treatment of said mammal based on a comparison of said first diagnostic disease score to said second diagnostic disease score. - View Dependent Claims (18, 19, 20, 21, 22)
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Specification