Trichotillomania is a common disorder characterized by plucking of hairs from head, eyelashes, eyebrows and, less commonly, from other parts of the body. While this behavior may rarely accompany classical obsessive compulsive disorder (OCD), the condition is not considered to be a part of OCD and usually is the only disorder present. Similarly onchyphagia (pathologic nail biting) may occasionally co-exist with OCD. However, most nail-biters do not show the obsessive compulsive disorder pattern of behavior and it is considered an independent entity. The Diagnostic and Statistical Manual of Mental Disorders, published by the American Psychiatric Association, Washington, 1987, describes compulsions occurring in OCD as "repetitive, " purposeful, and intentional behaviors that are performed in response to an obsession, according to certain rules or in a stereotyped fashion, while trichotillomania is defined as "recurrent failure to resist impulses to pull out one's hair, resulting in noticeable hair loss." DSM-III distinguishes between the two separate disorders suggesting a different etiology, natural history, and treatment response. Onchyphagia is not listed at all in DSM-III as a mental disorder. When onchyphagia and/or trichotillomania are present, self-consciousness about the behavior itself and the resulting disfigurement causes significant distress.
Several methods of treating hair-pulling and nail-biting have been tried heretofore including psychotherapy, behavior modification, hypnosis, relaxation therapy, and administration of varied pharmaceutical preparations. Beauticians have provided skin, hair, and nail treatments at high cost to patients While some of these approaches have proven to be efficacious in specific populations, no treatment has proven to be effective in treating a wide range of patients wherein the common problem pattern is trichotillomania or onchyphagia.
The 5-(3-dimethylaminopropyl)-10, 11-dehydro-5H-dibenzazepines of the formula ##STR1## have long been used as antidepressants. Yaryura-Tobias, et al. (Current therapeutic Research Vol. 20, No. 4, pp. 541-548), in 1976, described the use of clomipramine (compound of FIG. 1 where R=C1) for treatment of classical obsessive compulsive neurosis. In 1985, Krishnan, et al. published a review in which use of chlorpromazine, an antipsychotic drug unrelated to clomipramine, was suggested for use in treatment of trichotillomania if the hair-pulling resulted from schizophrenia or obsessive compulsive disorder. There has been no indication this drug should be used in treatment of primary trichotillomania.
Finally, the use of clomipramine in obsessive compulsive patients was believed by many authorities to be of value in treating OCD but only in patients having OCD accompanied by depression. For example, Marks and his associates stated, "When depression is minimal, clomipramine has no demonstrable value. . . . Clomipramine effects mood more than rituals." (Brit. J. Psychiat. (1980) 136, pp. 1-25 at 22. Others have found clomipramine's antiobsessional effect to be independent of its antidepressant activity.
USPTO Backgrounds
USPTO Backgrounds