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Title:  Methods and compositions for the diagnosis and treatment of neuropsychiatric disorders

United States Patent:  6,323,244

Inventors:  Chen; Hong (Brookline, MA); Freimer; Nelson B. (San Francisco, CA)

Assignee:   Millennium Pharmaceuticals, Inc. (Cambridge, MA); The Regents of the University of California (Oakland, CA)

Appl. No.:  965048

Filed:  November 5, 1997

Abstract

The present invention relates to the mammalian rTS gene, a gene associated with bipolar affective disorder (BAD) in humans. The invention relates to methods for the identification of compounds that modulate the expression of rTS and to using such compounds as therapeutic agents in the treatment of rTS disorders and neuropsychiatric disorders. The invention also relates to methods for the diagnostic evaluation, genetic testing and prognosis of rTS neuropsychiatric disorders including schizophrenia, attention deficit disorder, a schizoaffective disorder, a bipolar affective disorder or a unipolar affective disorder, and to methods and compositions for the treatment these disorders.

SUMMARY OF THE INVENTION

It is an object of the present invention to identify genetic bases for neuropsychiatric disorders, provide methods of treating and diagnosing neuropsychiatric disorders, and provide methods for identifying compounds for use as part of therapeutic and/or diagnostic methods.

In particular, the present invention relates, first, to the identification of the association of the mammalian rTS gene with neuropsychiatric disorders in humans, e.g., bipolar affective disorder.

The invention further relates to methods for the treatment of rTS mediated neuropsychiatric disorders, wherein such methods comprise administering a compound which modulates the expression of a mammalian rTS gene and/or the synthesis or activity of a mammalian rTS gene product so symptoms of the disorder are ameliorated.

The invention further relates to methods for the treatment of mammalian rTS mediated neuropsychiatric disorders resulting from rTS gene mutations, wherein such methods comprise supplying the mammal with a nucleic acid molecule encoding an unimpaired rTS gene product such that an unimpaired rTS gene product is expressed and symptoms of the disorder are ameliorated.

The invention further relates to methods for the treatment of mammalian rTS mediated neuropsychiatric disorders resulting from rTS gene mutations, wherein such methods comprise supplying the mammal with a cell comprising a nucleic acid molecule that encodes an unimpaired rTS gene product such that the cell expresses the unimpaired rTS gene product and symptoms of the disorder are ameliorated.

In addition, the present invention is directed to methods that utilize the rTS gene and/or gene product sequences for the diagnostic evaluation, genetic testing and prognosis of an rTS mediated neuropsychiatric disorder. For example, the invention relates to methods for diagnosing rTS mediated neuropsychiatric disorders, wherein such methods comprise measuring rTS gene expression in a patient sample, or detecting an rTS mutation in the genome of the mammal suspected of exhibiting such a disorder.

The invention still further relates to methods for identifying compounds capable of modulating the expression of the mammalian rTS gene and/or the synthesis or activity of the mammalian rTS gene products, wherein such methods comprise contacting a compound to a cell that expresses an rTS gene, measuring the level of rTS gene expression, gene product expression or gene product activity, and comparing this level to the level of rTS gene expression, gene product expression or gene product activity produced by the cell in the absence of the compound, such that if the level obtained in the presence of the compound differs from that obtained in its absence, a compound capable of modulating the expression of the mammalian rTS gene and/or the synthesis or activity of the mammalian rTS gene products has been identified.

rTS gene and/or gene products can also be utilized as markers for fine structure mapping of the region of the short arm of human chromosome 18 between the telomere and D185481.

The rTS mediated neuropsychiatric disorders referred to herein include, but are not limited to, bipolar affective disorder, e.g., severe bipolar affective (mood) disorder (BP-I), bipolar affective (mood) disorder with hypomania and major depression (BP-II).

The term "rTS mediated neuropsychiatric disorder" as used herein refers to a disorder involving an aberrant level of rTS gene expression, gene product synthesis and/or gene product activity relative to levels found in normal, unaffected, unimpaired individuals, levels found in clinically normal individuals, and/or levels found in a population whose level represents a baseline, average rTS level.

Claim 1 of 4 Claims

What is claimed is:

1. A method of treating a rTS-mediated neuropsychiatric disorder comprising identifying a compound that can be used to treat a rTS-mediated neuropsychiatric disorder, comprising the steps of:

a) contacting a small molecule test compound with an rTS protein;

b) determining whether said small molecule test compound binds to said rTS protein;

c) selecting a small molecule test compound that binds to said rTS protein as being a compound that can be used to treat an rTS-mediated neuropsychiatric disorder; and

d) administering said compound to a patient in need thereof.

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If you want to learn more about this patent, please go directly to the U.S. Patent and Trademark Office Web site to access the full patent.

 

 

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