Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
2002-04-19
2003-09-02
Henley, III, Raymond (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
active
06613763
ABSTRACT:
BACKGROUND OF THE INVENTION
Oppositional defiant disorder (ODD) and Conduct disorder (CD) are two of the most common psychiatric disorders affecting children and adolescents. Rates of ODD range from 2 to 16% depending on the nature of the population sample and methods of ascertainment. Rates of CD are in the same range. This translates into many millions of cases. The Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) characteristics of ODD include short temper, constant arguing with adults, defying rules, deliberately annoying others, blaming others for their own mistakes, being angry and resentful, spiteful and vindictive. In its severe form such children can be highly destructive to family life. Despite these characteristics no pharmaceutical companies market any medications specifically for ODD, and the majority of child psychiatrists feel it is largely a psychological disorder and make no effort to treat it medically.
The Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) characteristics of CD are a repetitive and persistent pattern of behavior in which the basic rights of others or major age-appropriate norms or rules are violated, as manifested by the presence of three or more of a range of criteria for 12 months. These include aggression to people and animals (bullying, threatening, starting fights, using a weapon to cause harm, being cruel to animal or people, stealing, forcing others into sexual activity), destruction of property, fire setting, deceitfulness or theft (broken into homes or property, stealing things of value), and serious violation of rules (staying out over night when less than 13 years of age, running away from home, truant from school before age 13).
The instant invention is the finding that ODD and CD can be treated with the drug molindone (Moban) which is a short acting atypical antipsychotic. Molindone is a dihydroindolone neuroleptic which is structurally distinct from other classes of neuroleptics. It exhibits many similarities to other neuroleptics, including dopamine receptor blockade, antipsychotic efficacy, and extrapyramidal side effects, yet molindone has atypical properties such as inhibiting the enzyme monoamine oxidase. Molindone is generally used for the treatment of schizophrenia and other psychotic disorders. Studies have been published in which molindone was tested for treatment of schizophrenia, anxiety and depression, and conduct disorder.
The publications and other materials used herein to illuminate the background of the invention or provide additional details respecting the practice, are incorporated by reference, and for convenience are respectively grouped in the appended List of References.
SUMMARY OF THE INVENTION
Molindone, a neuroleptic drug generally used to treat schizophrenia and other psychotic disorders, has been tested on children diagnosed with oppositional defiant disorder and conduct disorder and has been found to be an effective, treatment. Use of a preferred dose of 1.25 to 10 mg every 4 hours eliminates the symptoms of ODD or CD with minimal or no side effects.
Oppositional Defiant Disorder
Oppositional Defiant Disorder is one of the most common psychiatric disorders affecting children and adolescents. Rates of ODD range from 2 to 16% depending on the nature of the populations sample and methods of ascertainment. The place of ODD in the classification system was controversial when first introduced by the Diagnostic and Statistical Manual of Mental Disorders, Third Edition, revised (DSM-III-R) (American Psychiatric Association 1987). According to Rey (1993), some authors questioned whether oppositional defiant disorder was sufficiently distinct from normal oppositional behavior to warrant its inclusion as a distinct diagnostic category (Rutter and Shaffer, 1980) while other authors argued that the criteria for ODD implied a milder form of conduct disorder (Werry et al., 1983; Werry et al., 1987). Despite this early controversy, ODD has become one of the diagnoses more commonly made in clinical setting and community samples (Rey, 1993).
Probably as a result of the original controversy concerning whether ODD was a distinct 15 diagnostic category, the concept of ODD underwent considerable changes. DSM-III introduced oppositional disorder in the category Disorders Usually First Evident in Infancy, Childhood or Adolescence to describe children who show a persistently disobedient, negativistic, and provocative opposition to authority figures, manifested by at least two of the following symptoms: 1) violations of minor rules, 2) temper tantrums, 3) argumentativeness, 4) provocative behavior, and 5) stubbornness. This diagnosis was placed under the heading Other Disorders of Infancy, Childhood and Adolescence, together with diagnoses such as schizoid disorder, elective mutism, and identity disorder (Rey, 1993). The International Classification of Diseases 9 (ICD-9 (World Health Organization)) did not contain a comparable diagnosis. Seven years later, DSM-I11-R changed the name to oppositional defiant disorder and placed it, together with conduct disorder and attention deficit hyperactivity disorder, under the heading Disruptive Behavior Disorders (Rey, 1993). The number of diagnostic criteria was increased to nine by the addition of 1) blames others for his or her own mistakes, 2) is touchy or easily annoyed, 3) is angry and resentful, 4) is spiteful or vindictive, and 5) swears, and by the removal of stubbornness; the remaining four criteria were reworded (e.g., temper tantrums became “often loses temper”) (Rey, 1993). Also, the number of criteria required for the diagnosis was increased to five. These modifications were designed to counter the criticism that ODD could not be distinguished from the behavior of many normal children and the changes were well received (Rey, 1993; Rutter, 1988). In both DSM-I11 and DSM-I11-R, a diagnosis of oppositional defiant disorder can be made only in the absence of conduct disorder (Rey, 1993).
The 4th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) 5 came into use in 1994 (American Psychiatric Association, 1994). It defines the essential feature of ODD as a recurrent pattern of negativistic, defiant, disobedient, and hostile behavior toward authority figures that persists for at least 6 months (Criterion A) and is characterized by the frequent occurrence of at least four of the following behaviors: losing temper (Criterion Al), arguing with adults (Criterion A2), actively defying or refusing to comply with the requests or rules of adults (Criterion A3), deliberately doing things that will annoy other people (Criterion A4), blaming others for his or her own mistakes or misbehavior (Criterion AS), being touchy or easily annoyed by others (Criterion A6), being angry and resentful (Criterion A7), or being spiteful or vindictive (Criterion A8). To qualify for ODD, the behaviors must occur more frequently than is typically observed in individuals of comparable age and developmental level and must lead to significant impairment in social, academic, or occupational functioning (Criterion B). The diagnosis is not made if the disturbance in behavior occurs exclusively during the course of a Psychotic or Mood Disorder (Criterion C) or if criteria are met for Conduct Disorder or Antisocial Personality Disorder (in an individual over age 18 years) (DSM-IV, American Psychiatric Association, 1994) Although ODD includes some of the features observed in Conduct Disorder (e.g., disobedience and opposition to authority figures), it does not include the persistent pattern of the more serious forms of behavior in which either the basic rights of others or age-appropriate societal norms or rules are violated (DSM-IV, American Psychiatric Association, 1994). When the individual's pattern of behavior meets the criteria for both Conduct Disorder and ODD, the diagnosis of Conduct Disorder takes precedence and ODD is not diagnosed (DSM-W, American Psychiatric Association, 1994). ICD-10 (World Health Organization, 1992) als
Comings David E.
Kovacs Bruce
MacMurry Jim
Henley III Raymond
MGI Applied Genomics
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