Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing other than solely as a nitrogen in an...
Reexamination Certificate
2000-03-24
2002-05-14
Krass, Frederick (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Nitrogen containing other than solely as a nitrogen in an...
C514S217000, C514S321000, C514S647000, C514S651000, C514S654000, C514S657000, C424S449000
Reexamination Certificate
active
06387956
ABSTRACT:
TECHNICAL FIELD
This invention relates to methods of treating obsessive-compulsive spectrum disorders. More particularly, the invention relates to methods of treating obsessive-compulsive spectrum disorders comprising the step of administering an effective amount of tramadol to an individual.
BACKGROUND ART
Although originally believed to be rare, it is now known that obsessive-compulsive disorder (OCD) is common, with estimated life time prevalence rates in the United States ranging from 1.9% to 3.3% (Shapira et al.,
Depression and Anxiety
6; 170-173 (1997).)
The Diagnostic and Statistical Manual of Mental Disorders,
fourth edition, (DSM-IV), includes as its diagnostic criteria for OCD that: the person exhibits either obsessions or compulsions; at some point during the course of the disorder the person has recognized that the obsessions or compulsions are excessive or unreasonable; the obsessions or compulsions caused marked stress, are time-consuming or significantly interfere with the person's normal routine, occupational/academic functioning, or usual social activities or relationships; if another axis I disorder is present, the content of the obsessions or compulsions is not restricted to it; and the disturbance is not due to the direct physiologic effects of a substance or a general medical condition.
The DSM-IV sets four indicia of obsessions. First, the person has recurrent and/or persistent thoughts, impulses or images that are experienced at some time during the disturbance as intrusive and inappropriate and as causing marked anxiety or distress. Second, the thoughts, impulses or images are not simply excessive worries about real-life problems. Third, the person attempts to ignore or suppress such thoughts, impulses or images or to neutralize them through some other thought or action. Fourth, the person recognizes that the obsessional thoughts, impulses, or images are products of his or her own mind and are not imposed from without.
The DSM-IV sets forth two indicia of compulsion. First, the person has repetitive behaviors or mental acts that the person feels driven to perform in response to an obsession or according to rules that must be applied rigidly. Repetitive behaviors include hand washing, ordering and checking, while mental acts include praying, counting and repeating words silently. Second, the behaviors or mental acts are aimed at preventing some dreaded event or situation; however, these behaviors or mental acts either are not connected in a realistic way to what they are designed to neutralize or prevent, or are clearly excessive.
Individuals who meet the DSM-IV criteria for OCD can be scored using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Y-BOCS scores range from 0 to 40. Generally, 0 to 7 is considered a subclinical syndrome, 8-15 is considered mild, 16-23 is considered moderate, 24-31 is considered severe, and 32-40 is considered extremely severe.
A wide range of psychiatric and neuropsychiatric disorders appear to be related to OCD and form a family of related disorders referred to as obsessive-compulsive (OC) spectrum disorders. Obsessive-compulsive spectrum disorders include somatoform disorders, eating disorders, impulse control disorders (ICDs), paraphilia and nonparaphilic sexual addictions, Sydeham's chorea, torticollis, autism, and movement disorders, including Tourette's syndrome. As used herein, “obsessive-compulsive spectrum disorders” is intended to include OCD.
Somatoform disorders include body dysmorphic disorder (BDD) and hyperchondriasis. Body dysmorphic disorder (BDD) is a preoccupation with an imagined slight defect in appearance that causes significant distress or impairment in functioning. Individuals suffering from BDD have preoccupations similar to OCD obsessions in that they have repetitive intrusive thoughts, often perform time-consuming, repetitive and sometimes ritualistic behaviors. Hypochondriasis is a preoccupation with the fear of having, or the idea that one has, a serious disease based on the person's misinterpretation of bodily signs or symptoms. Hypochondriacal preoccupations resemble OCD obsessions in that they are often experienced as intrusive and persistent, and the individuals often display repetitive checking behaviors.
Eating disorders include anorexia nervosa, bulimia nervosa and binge eating disorder (BED). The DSM-IV defines anorexia nervosa as a refusal to maintain a minimally normal body weight; intensive fear of gaining weight or becoming fat even though underweight; significant disturbance in perception of body shape or size; and, in females, amenorrhea. The DSM-IV defines bulimia nervosa as recurrent episodes of binge eating followed by inappropriate compensatory behaviors designed to prevent a weight gain. BED is characterized by recurrent episodes of binge eating in the absence of regular use of inappropriate compensatory behaviors. There is some overlap among anorexia nervosa, bulimia nervosa, and BED. However, all three disorders are characterized by a core preoccupation with food and body weight. Individuals suffering from eating disorders often perform specific rituals, and have an abnormal preoccupation with food and weight.
The DSM-IV defines an impulse control disorder (ICD) as the failure to resist the impulse, drive or temptation to perform some act that is harmful. ICDs include intermitted explosive disorder (IED), compulsive buying or shopping, repetitive self-mutilation (RSM), onychophagia, psychogenic excoriation, kleptomania, pathological gambling, and trichotillomania. Most individuals suffering from ICDs experience increasing sense of tension or arousal before committing the act, then pleasure, gratification or relief at the time of committing the act. Individuals suffering from ICD often experience impulses which are intrusive, persistent and associated with anxiety or tension. Individuals suffering from paraphilias and nonparaphilic sexual addictions (NPSAs) experience similar increasing senses of tension or arousal before committing the act, then pleasure, gratification or relief at the time of committing the act.
Tourette's syndrome is a chronic neuropsychiatric disorder characterized by motor tics and one or more vocal tics beginning before the age of 18 years. The DSM-IV defines a tic as a sudden, rapid, recurrent, nonrhythmic, stereotyped motor movement or vocalization. Tourette's syndrome patients may be able to suppress tics for varying lengths of time, but eventually experience them as irresistible and perform them. Tourette's patients exhibit obsessions resembling OCD obsessions, for example, they often feel the need to perform tics until they are felt to be “just right.”
Autism is characterized by difficulties with social interaction, speech and communication, and by a compulsive core. Autistic individuals often display compulsive, repetitive behaviors.
Behavior modification therapy is often efficacious in treating obsessive-compulsive spectrum disorders, including OCD. However, behavior modification therapy generally requires prolonged periods of treatment. Also, an individual may not respond favorably to behavior modification therapy unless the severe OC spectrum disorder symptoms are first controlled or decreased. Thus, it is often desirable to supplement the initial stages of behavior modification with drug therapy. Preferably, the drug therapy will be one that has a short onset of action, preferably less than two weeks.
Some OC spectrum disorders, such a bulimia nervosa, have been shown to respond to monoamine oxidase inhibitors (MAOIs). Unfortunately, people who use MAOIs adhere to numerous dietary restrictions and observe special precautions to avoid drug interactions.
OCD has been treated with serotonin reuptake inhibitors (SRIs) such as clomipramine, fluoxetine, fluvoxamine, sertraline and paroxetine. There is also evidence to suggest that Tourette's syndrome, hypochondriasis, anorexia nervosa, and ICDs such as intermitted explosive disorder (IED), kleptomania, pathological gambling, trichotillomania, compulsiv
Goldsmith Toby D.
Keck, Jr. Paul E.
Shapira Nathan A.
Dinsmore & Shohl LLP
Krass Frederick
University of Cincinnati
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