Method of treating psychiatric conditions

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...

Reexamination Certificate

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C544S368000

Reexamination Certificate

active

06245766

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates to the use of piperazinyl-heterocyclic compounds of the formula I, as defined below, for the treatment of certain psychiatric disorders and conditions that have as symptoms behavioral disturbances. Such psychiatric disorders and conditions include anxiety disorders such as generalized anxiety disorder, panic disorder, posttraumatic stress disorder and phobias; psychotic episodes of anxiety, anxiety associated with psychosis, psychotic mood disorders such as severe major depressive disorder; mood disorders associated with psychotic disorders such as acute mania and depression associated with bipolar disorder, mood disorders associated with schizophrenia; behavioral disturbances associated with mental retardation, autistic disorder, and conduct disorder; dementias such as dementias associated with Alzheimer's disease; and drug-induced and neurodegeneration based dyskinesias.
The piperazinyl-heterocyclic compounds of formula I of this invention, useful in the treatment of psychotic disorders, are referred to in U.S. Pat. Nos. 4,831,031 and 4,883,795, both of which are assigned in common with the present application.
SUMMARY OF THE INVENTION
The present invention relates to a method for treating a psychiatic condition or disorder selected from anxiety disorders such as generalized anxiety disorder, panic disorder, posttraumatic stress disorder and phobias; psychotic episodes of anxiety, anxiety associated with psychosis, psychotic mood disorders such as severe major depressive disorder; mood disorders associated with psychotic disorders such as acute mania or depression associated with bipolar disorder and mood disorders associated with schizophrenia, behavioral manifestations of mental retardation, conduct disorder and autistic disorder; dementias such as dementias of the Alzheimer's type; and dyskinesias such as drug induced and neurodegeneration based dyskinesias in a mammal, including a human, comprising administering to said mammal a pharmaceutically effective amount of a compound of the formula
or a pharmaceutically acceptable acid addition salt thereof, wherein
Ar is benzoisothiazolyl or an oxide or dioxide thereof each optionally substituted by one fluoro, chloro, trifluoromethyl, methoxy, cyano, nitro or naphthyl optionally substituted by fluoro, chloro, trifluoromethyl, methoxy, cyano or nitro; quinolyl; 6-hydroxy-8-quinolyl; isoquinolyl; quinazolyl; benzothiazolyl; benzothiadiazolyl; benzotriazolyl; benzoxazolyl; benzoxazolonyl; indolyl; indanyl optionally substituted by one or two fluoro, 3-indazolyl optionally substituted by 1-trifluoromethylphenyl; or phthalazinyl;
n is 1 or 2; and
X and Y together with the phenyl to which they are attached form quinolyl; 2-hydroxyquinolyl; benzothiazolyl; 2-aminobenzothiazolyl; benzoisothiazolyl; indazolyl; 2-hydroxyindazolyl; indolyl; spiro; oxindolyl optionally substituted by one to three of (C
1
-C
3
)alkyl, or one of chloro, fluoro or phenyl, said phenyl optionally substituted by one chloro or fluoro; benzoxazolyl; 2-aminobenzoxazolyl; benzoxazolonyl; 2-aminobenzoxazolinyl; benzothiazolonyl; bezoimidazolonyl; or benzotriazolyl. The foregoing method is referred to hereinafter as the “inventive method”.
The term “treating”, as used herein, refers to reversing, alleviating, inhibiting the progress of, or preventing the disorder or condition to which such term applies, or one or more symptoms of such disorders or condition. The term “treatment”, as used herein, refers to the act of treating, as “treating” is defined immediately above.
The term “pharmaceutically effective amount”, as used herein, refers to an amount of the compound of formula I sufficient to treat a psychiatic condition or disorder selected from anxiety disorders such as generalized anxiety disorder, panic disorder, posttraumatic stress disorder and phobias; psychotic episodes of anxiety, anxiety associated with psychosis; psychotic mood disorders such as severe major depressive disorder; mood disorders associated with psychotic disorders such as acute mania or depression associated with bipolar disorder; mood disorders associated with schizophrenia; behavioral manifestations of mental retardation, conduct disorder and autistic disorder; dementias such as dementias of the Alzheimer's type; and dyskinesias such as drug induced and neurodegeneration based dyskinesias in a mammal, including a human.
A preferred embodiment of this invention relates to the above inventive method wherein the compound administered is used for treating dementia.
Another preferred embodiment of this invention relates to the above inventive method wherein dementia that is treated is selected from the group consisting of vascular dementia, dementia due to HIV disease, dementia due to head trauma, dementia due to Parkinson's disease, dementia due to Huntington's disease, dementia due to Pick's disease, dementia due to Creutzfeldt-Jakob disease, substance-induced persisting dementia, dementia due to multiple etiologies and dementia not otherwise specified (NOS).
Another preferred embodiment of this invention relates to the above inventive method wherein the compound administered is used for treating dementia of the Alzheimer's type.
Another preferred embodiment of this invention relates to the above inventive method wherein the dementia that is treated is dementia of the Alzheimer's type and is selected from the group consisting of dementia of the Alzheimer's type with early onset uncomplicated, dementia of the Alzheimer's type with early onset with delusions, dementia of the Alzheimer's type with early onset with depressed mood, dementia of the Alzheimer's type with late onset uncomplicated, dementia of the Alzheimer's type with late onset with delusions and dementia of the Alzheimer's type with late onset with depressed mood.
Another preferred embodiment of this invention relates to the above inventive method wherein the compound administered is used for treating generalized anxiety disorder.
Another preferred embodiment of this invention relates to the above inventive method wherein the anxiety disorder is selected from the group consisting of panic disorder without agoraphobia, panic disorder with agoraphobia, agoraphobia without history of panic disorder, social phobia, postraumatic stress disorder, acute stress disorder, generalized anxiety disorder, substance-induced anxiety disorder and anxiety disorder not otherwise specified (NOS).
Another preferred embodiment of this invention relates to the above inventive method wherein the compound administered is used for treating a psychotic mood disorder.
Another preferred embodiment of this invention relates to the above inventive method wherein psychotic mood disorder is selected from the group consisting of depressive disorders, bipolar disorders, mood disorder with depressive features, mood disorder with major depressive-like episode, mood disorder with manic features, mood disorder with mixed features, substance-induced mood disorder and mood disorder not otherwise specified (NOS).
Another preferred embodiment of this invention relates to the above inventive method wherein depressive disorders are selected from major depressive disorder (single episode) and major depressive disorder (recurrent).
Another preferred embodiment of this invention relates to the above inventive method wherein the current state of major depressive disorder (single episode) and major depressive disorder (recurrent) are each characterized as mild, moderate, severe without psychotic features, severe with psychotic features, in partial remission or in full remission.
Another preferred embodiment of this invention relates to the above inventive method wherein bipolar disorders are selected from the group consisting of bipolar I or II disorder (single manic episode), bipolar I or II disorder (most recent episode hypomanic), bipolar I or II disorder (most recent episode manic, bipolar I or II disorder most recent episode mixed, bipolar I or II

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