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  Methods for diagnosing schizophreniaUSPTO Application #: 20080113393Title: Methods for diagnosing schizophrenia Abstract: The invention relates to the use of Reelin as a marker for diagnosing psychiatric conditions. The disclosed tools and techniques can facilitate the diagnosis of psychiatric disorders including major depression, bipolar disorder, schizophrenia and autism. (end of abstract)
Agent: Fish & Richardson P.c. - Minneapolis, MN, US Inventor: S. Hossein Fatemi USPTO Applicaton #: 20080113393 - Class: 435007920 (USPTO) Related Patent Categories: Chemistry: Molecular Biology And Microbiology, Measuring Or Testing Process Involving Enzymes Or Micro-organisms; Composition Or Test Strip Therefore; Processes Of Forming Such Composition Or Test Strip, Involving Antigen-antibody Binding, Specific Binding Protein Assay Or Specific Ligand-receptor Binding Assay, Assay In Which An Enzyme Present Is A Label, Heterogeneous Or Solid Phase Assay System (e.g., Elisa, Etc.) The Patent Description & Claims data below is from USPTO Patent Application 20080113393. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a Divisional application of, and claims the benefit of priority under 35 U.S.C. .sctn.120 to, U.S. application Ser. No. 10/346,910 filed Jan. 16, 2003, which claims priority under 35 U.S.C. .sctn.119(e) of U.S. Application No. 60/349,846 filed Jan. 16, 2002. TECHNICAL FIELD [0002] This invention relates to the use of polypeptide markers for diagnosing psychiatric conditions. BACKGROUND [0003] Reelin is a glycoprotein that seems to have a role in central nervous system development. Reelin was discovered via studies of "reeler" mice, autosomal recessive mutants that have an ataxic and reeling gait. Reeler mice have numerous central nervous system defects, including cerebellar hypoplasia, abnormal neuronal positioning, aberrant orientation of cell bodies and fibers, inverted cortical lamination, and neuronal ectopia in laminated brain structures (e.g., cerebral and cerebellar cortices and hippocampus). [0004] Neuroanatomical defects such as those observed in reeler mice can adversely affect synaptic connectivity and can impair normal brain function. Reelin levels are reportedly altered in the brains of some humans afflicted with major depression, bipolar disorder and schizophrenia, suggesting that Reelin may be involved in cell signaling systems underlying brain cognitive functions. See, e.g., Impagnatiello et al., 1998, Proc. Natl. Acad. Sci. USA, 95:15718-15723; Fatemi et al., 2000, Mol. Psychiatry, 5:654-663; Guidotti et al., Arch. Gen. Psychiatry, 57:1061-9; and Fatemi et al., 2001 Neuro. Report, 12:3209-3215. SUMMARY [0005] The methods and materials of the present invention can be used to facilitate diagnosis of psychiatric conditions. The invention is based, at least in part, on the discovery that blood levels of Reelin moieties are altered in patients afflicted with major depression, bipolar disorder, schizophrenia and autism. These and other psychiatric conditions can decrease the life quality of affected persons and can present a risk of harm to those affected and to others. Complicating matters, psychiatric disorders having different causal elements and different treatment protocols can have confusingly similar clinical symptoms. The disclosed tools and techniques can facilitate the diagnosis of psychiatric conditions and thereby improve therapy decisions and patient outcomes. [0006] In one aspect, the invention features methods for diagnosing a psychiatric condition in a patient. The methods involve: comparing the level of at least one Reelin moiety in a biological sample from a patient with the level of a corresponding Reelin moiety in one or more control subjects, and diagnosing the condition based on the comparison. In some embodiments, the methods involve comparing the levels of two or more Reelin moieties in a biological sample from a patient with the levels of corresponding Reelin moieties in control subjects, and diagnosing the condition based on the comparison. [0007] The psychiatric condition can be, for example, major depression, schizophrenia, bipolar disorder and autism. Suitable biological samples can include blood (including whole blood, plasma and serum), urine, and cerebral spinal fluid. The levels of Reelin moieties in biological samples can be determined using an immunoassay (e.g., ELISA) that employs monoclonal or polyclonal antibodies to capture Reelin moieties. Reelin moieties can include, for example, full-length Reelin, natural proteolytic cleavage products of Reelin and post-translationally modified Reelin polypeptides. Particularly suitable Reelin moieties have apparent molecular masses of about 410 kDa, about 330 kDa and about 180 kDa. [0008] A diagnosis of major depression can be made if the level of a Reelin moiety having an apparent molecular mass of about 410 kDa is not different from, or is increased relative to, control subjects, and the level of a Reelin moiety having an apparent molecular mass of about 180 kDa is decreased relative to control subjects. In addition, a diagnosis of major depression can be made if the level of a Reelin moiety having an apparent molecular mass of about 330 kDa is not different from, or is increased relative to, control subjects. [0009] A diagnosis of major depression can be made if the level of a Reelin moiety having an apparent molecular mass of about 330 kDa is not different from, or is increased relative to, control subjects, and the level of a Reelin moiety having an apparent molecular mass of about 180 kDa is decreased relative to control subjects. A diagnosis of major depression also can be made if the level of a Reelin moiety having an apparent molecular mass of about 410 kDa is not different from, or is increased relative to, control subjects. [0010] A diagnosis of major depression can be made if the level of a Reelin moiety having an apparent molecular mass of about 410 kDa is not different from, or is increased relative to, control subjects, and the level of a Reelin moiety having an apparent molecular mass of about 330 kDa is not different from, or is increased relative to, control subjects. A diagnosis of major depression also can be made if the level of a Reelin moiety having an apparent molecular mass of about 180 kDa is decreased relative to control subjects. [0011] A diagnosis of schizophrenia can be made if the level of a Reelin moiety having an apparent molecular mass of about 410 kDa is increased relative to control subjects, and the level of a Reelin moiety having an apparent molecular mass of about 180 kDa is not different from, or is decreased relative to, control subjects. A diagnosis of schizophrenia also can be made if the level of a Reelin moiety having an apparent molecular mass of about 330 kDa is increased relative to control subjects. [0012] A diagnosis of schizophrenia can also be made if the level of a Reelin moiety having an apparent molecular mass of 330 kDa is increased relative to control subjects, and the level of a Reelin moiety having an apparent molecular mass of about 180 kDa is not different from, or is decreased relative to, control subjects. A diagnosis of schizophrenia also can be made if the level of a Reelin moiety having an apparent molecular mass of about 410 kDa is increased relative to control subjects. [0013] A diagnosis of schizophrenia can also be made if the level of a Reelin moiety having an apparent molecular mass of about 410 kDa is increased relative to control subjects, and the level of a Reelin moiety having an apparent molecular mass of about 330 kDa is increased relative to control subjects. A diagnosis of schizophrenia also can be made if the level of a Reelin moiety having an apparent molecular mass of about 180 kDa is not different from, or is decreased relative to, control subjects. [0014] A diagnosis of bipolar disorder can be made if the level of a Reelin moiety having an apparent molecular mass of about 410 kDa is not different from, or is decreased relative to, control subjects, and the level of a Reelin moiety having an apparent molecular mass of about 180 kDa is decreased relative to control subjects. A diagnosis of bipolar disorder also can be made if the level of a Reelin moiety having an apparent molecular mass of about 330 kDa is decreased relative to control subjects. [0015] A diagnosis of bipolar disorder can be made if the level of a Reelin moiety having an apparent molecular mass of about 330 kDa is decreased relative to control subjects, and the level of a Reelin moiety having an apparent molecular mass of about 180 kDa is decreased relative to control subjects. A diagnosis of bipolar disorder also can be made if the level of a Reelin moiety having an apparent molecular mass of about 410 kDa is not different from, or is decreased relative to, control subjects. [0016] A diagnosis of bipolar disorder can be made if the level of a Reelin moiety having an apparent molecular mass of about 410 kDa is not different from, or is decreased relative to, control subjects, and the level of a Reelin moiety having an apparent molecular mass of about 330 kDa is decreased relative to control subjects. A diagnosis of bipolar disorder also can be made if the level of a Reelin moiety having an apparent molecular mass of about 180 kDa is decreased relative to control subjects. [0017] A diagnosis of autism can be made if the level of a Reelin moiety having an apparent molecular mass of about 410 kDa is decreased relative to control subjects, and the level of a Reelin moiety having an apparent molecular mass of about 180 kDa is not different from, or is increased relative to, control subjects. A diagnosis of autism also can be made if the level of a Reelin moiety having an apparent molecular mass of about 330 kDa is not different from, or is increased relative to, control subjects. [0018] A diagnosis of autism can be made if the level of a Reelin moiety having an apparent molecular mass of about 330 kDa is not different from, or is increased relative to, control subjects, and the level of a Reelin moiety having an apparent molecular mass of about 180 kDa is not different from, or is increased relative to, control subjects. A diagnosis of autism also can be made if the level of a Reelin moiety having an apparent molecular mass of about 410 kDa is decreased relative to control subjects. [0019] A diagnosis of autism can be made if the level of a Reelin moiety having an apparent molecular mass of about 410 kDa is decreased relative to control subjects, and the level of a Reelin moiety having an apparent molecular mass of about 330 kDa is not different from, or is increased relative to, control subjects. A diagnosis of autism also can be made if the level of a Reelin moiety having an apparent molecular mass of about 180 kDa is not different from, or is increased relative to, control subjects. [0020] The invention additionally features methods of diagnosing autism in an unborn child. Such a method includes comparing the level of at least one Reelin moiety in a biological sample from a biological parent or biological sibling of the unborn child with the level of a corresponding Reelin moiety in one or more control subjects, and diagnosing autism based on the comparison. Representative biological samples include whole blood, plasma, and serum. Continue reading... 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