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

摘要

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, 4-HNE, and/or hsCRP) 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 at least one symptom (e.g., at least one core symptom) of depression in a subject and/or determining or improving the effectiveness of an antidepressant drug taken by a subject are also provided herein.

主权项

1. A method for treating at least one symptom of depression in a human subject, said method comprising:
assaying a biological sample from said human subject who has been diagnosed with depression, and detecting in the biological sample a combination of the following biomarkers:
i. a SNP at position 27 of SEQ ID NO. 18 (rs8007267) comprising at least one thymine “T” allele or the complement thereof, wherein the SEQ ID NO. 18 is a portion of a genomic nucleic acid sequence of GTP cyclohydrolase 1 (GCH1); andii. a SNP at position 27 of SEQ ID NO. 24 (rs4680) comprising two guanine “G” alleles or the complement thereof, wherein the SEQ ID NO. 24 is a portion of a genomic nucleic acid sequence of catechol-O-methyltransferase (COMT), thereafter, administering a composition comprising an effective amount of a folate-containing compound, wherein said folate containing compound is at least 15 mg/day of 6-(S) 5-methyltetrahydrofolate, together with an antidepressant drug, wherein the antidepressant drug is a selective serotonin reuptake inhibitor, to the human subject to treat depression.