Methods for objective assessment, risk prediction, matching to existing medications and new methods of using drugs, and monitoring responses to treatments for mood disorders
OwnerAlexander B. Niculescu, IIIinventor
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Abstract
Methods for objective and precise assessment, risk prediction, monitoring of disease course and response to treatment, and precise matching to existing, and to new method of use repurposed drugs, in mood disorders, such as for patients with depression or bipolar disorder. These methods are based on an objective analysis of specific biomarker panels, as well as on the integration of the biomarker panel data with clinical measures of mood, life satisfaction, psycho-socio-demographic risk factors, and clinical history severity. These methods provide a foundation for precision medicine for mood disorders.
Claims31
A method for diagnosing and treating mood disorders in an individual in need thereof, comprising:
- (a) measuring the expression levels and/or slope of biomarkers in a biological sample from an individual, wherein the biomarkers in a first panel of biomarker comprise one or more of:
- TMEM161B, GLO1, PRPS1, SMAD7, ANK3, OGT, CD47, GLS, TMEM106B, RPL3, FANCF, HNRNPDL, DOCK10, or CALM1, and
- wherein the biomarkers in a second panel of biomarkers comprise one or more of:
- NRG1, OLFM1, SPECC1, SORT1, TPH1, GSK3B, MARCKS, NR3C1, and SLC6A4;
- (b) comparing the expression level or slope of each biomarker measured in the sample to the expression level and/or slope of a matched biomarker determined in a clinically relevant population;
- (c) generating a score for the individual, wherein the score is determined by summing:
- the number of biomarkers in the first panel of biomarkers exhibiting changed expression and/or slope relative to the expression level and/or slope in the matched biomarkers determined in the clinically relevant population and
- the number of biomarkers in the second panel of biomarkers expressing changed expression and/or slope relative to the expression level and/or slope in the matched biomarkers determined in the clinically relevant population
- (d) diagnosing the individual as having a mood disorder, and/or an increased risk for developing a mood disorder risk based on the difference between the scores of the individual and the scores of the matched biomarkers in the clinically relevant population;
- and
- (e) treating the individual diagnosed with a mood disorder, and or the individual diagnosed with an increased risk for developing a mood disorder.
A method for monitoring response to treatment of a mood disorder and determining treatment efficacy in an individual, comprising the steps of:
- (a) measuring an expression levels of biomarkers in at least 2 biological samples from the individual and comparing the measured expression levels to an expression level of a matched biomarker determined in a clinically relevant population, wherein the at least one biomarker is from a first panel, comprising:
- TMEM161B, GLO1, PRPS1, SMAD7, ANK3, OGT, CD47, GLS, TMEM106B, RPL3, FANCF, HNRNPDL, DOCK10, and CALM1, and/or
- wherein the at least one biomarker is from a second panel comprising:
- NRG1, OLFM1, SPECC1, SORT1, TPH1, GSK3B, MARCKS, NR3C1, and SLC6A4, wherein the expression level of the one or more biomarkers in the biological sample is changed, and wherein at least one of the at least two biological samples is collected before the individual is treated for a mood disorder and at least one of the at least two biological samples is collected after the individual is treated for a mood disorder;
- (b) calculating a score for the biomarkers in the biological samples, by summing:
- the number of biomarkers in the first panel exhibiting a change in expression level relative to the expression of the biomarker determined in a clinically relevant population, and/or
- the number of biomarkers in the second panel exhibiting a change in expression level relative to the expression of the biomarker determined in a clinically relevant population;
- and
- (c) determining that said treatment(s) is effective if the score of the panel of biomarker(s) in the sample collected after treatment is lower than the score of at least one of the at least two biologicals samples collected before treatment.
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Dependencies are inferred from the claim text.