Botulinum Toxin and the Treatment of Primary Disorders of Mood and Affect

Abstract

The invention provides methods for treating primary disorders of mood and affect, including depressive disorders, anxiety and sleep disorders and CNS disorders comprising the administration of a neurotoxin.

We claim: 
     
         1 . A method of treating depression comprising the steps of: a) identifying a subject with a depressive disorder or identifying a subject with one or more symptoms of a depressive disorder; and b) administering an effective amount of a composition comprising a  botulinum  toxin and a pharmaceutically acceptable carrier to said subject thereby reducing at least one symptom of depression. 
     
     
         2 . The method of  claim 1 , wherein the  botulinum  toxin is immunotype A, B, C, D, E, F, or G. 
     
     
         3 . The method of  claim 1 , wherein the  botulinum  toxin is  botulinum  toxin type A from Hall strain  Clostridium botulinum.    
     
     
         4 . The method of  claim 1 , wherein the composition is administered by injection. 
     
     
         5 . The method of  claim 1 , wherein there are at least two injection sites. 
     
     
         6 . The method of  claim 4 , wherein the injection is multifocal. 
     
     
         7 . The method of  claim 4 , wherein the composition is administered to the forehead. 
     
     
         8 . The method of  claim 4 , wherein the composition is administered to the scalp. 
     
     
         9 . The method of  claim 4 , wherein the composition is administered to the neck. 
     
     
         10 . The method of  claim 1 , wherein said administration of said  botulinum  toxin blocks at least one neurotransmitter. 
     
     
         11 . The method of  claim 10 , wherein said at least one neurotransmitter is at least one of acetylcholine, glutamate, and norepinephrine. 
     
     
         12 . A method of treating depression comprising administering a therapeutically effective amount of a  botulinum  toxin subdermally, non-intramuscularly to a face of a subject with depression, thereby treating the depression by reducing the occurrence of a symptom of the depression. 
     
     
         13 . The method of  claim 12 , wherein the step of administering further comprises administering the  botulinum  toxin to a periocular region of the face. 
     
     
         14 . The method of  claim 12 , wherein the step of administering further comprises administering the  botulinum  toxin to areas of the face that enhance venous drainage from the site of administration to the central nervous system. 
     
     
         15 . The method of  claim 12 , wherein the step of administering further comprises administering the  botulinum  toxin to locations that maximize uptake by a portal hypophyseal drainage. 
     
     
         16 . The method of  claim 12 , wherein the  botulinum  toxin is a botulinum toxin type A. 
     
     
         17 . The method of  claim 12 , wherein the  botulinum  toxin is administered subdermally. 
     
     
         18 . The method of  claim 12 , wherein the  botulinum  toxin is administered non-intramuscularly. 
     
     
         19 . The method of  claim 12 , wherein the  botulinum  toxin is administered directly. 
     
     
         20 . The method of  claim 12 , wherein the  botulinum  toxin administered further comprises a therapeutically effective amount of the  botulinum toxin.    
     
     
         21 . The method of  claim 12 , wherein the step of administering further comprises locally administering a therapeutically effective amount of the  botulinum  toxin subdermally, non-intramuscularly to the face of a patient with depression. 
     
     
         22 . The method of  claim 12 , wherein the symptom of depression further comprises at least one of the group consisting of:
 depressed mood;   markedly diminished interest or pleasure in activities;   significant weight loss or gain;   insomnia or hypersomnia;   psychomotor agitation, anxiety, or retardation;   fatigue or energy loss;   feelings of guilt and worthlessness;   impaired concentration and indecisiveness; and   recurring thoughts of death or suicide.   
     
     
         23 . The method of  claim 22 , wherein the  botulinum  toxin is a  botulinum  toxin type A. 
     
     
         24 . The method of  claim 22 , wherein the  botulinum  toxin is administered subdermally. 
     
     
         25 . The method of  claim 22 , wherein the  botulinum  toxin is administered non-intramuscularly. 
     
     
         26 . The method of  claim 22 , wherein the  botulinum  toxin is administered directly. 
     
     
         27 . The method of  claim 22 , wherein the  botulinum  toxin administered further comprises a therapeutically effective amount of the  botulinum  toxin. 
     
     
         28 . The method of  claim 22 , wherein the step of administering further comprises locally administering a therapeutically effective amount of the  botulinum  toxin subdermally, non-intramuscularly to the face of a patient with depression. 
     
     
         29 . The method of  claim 12 , wherein the depression further comprises one of the group consisting of: major depression; dysthymia; minor depression; seasonal affective disorder; and atypical depression. 
     
     
         30 . A method for treating a neurological disorder selected from the group consisting of seizure disorders, chronic surgical wound pain, pain syndrome, myofascial pain, muscle tension headache, or trigeminal neuralgia, comprising the step of locally administering a  botulinum  toxin to at least one of a scalp, face, or neck of a patient with the neurological disorder, thereby treating the neurological disorder by reducing the occurrence of a symptom of the neurological disorder. 
     
     
         31 . The method of  claim 30 , wherein the  botulinum  toxin is selected from the group consisting of  botulinum  toxin types A, B, C.sub.1, D, E, F and G. 
     
     
         32 . The method of  claim 30 , wherein the  botulinum  toxin is a  botulinum  toxin type A. 
     
     
         33 . The method of  claim 30 , wherein the  botulinum  toxin is administered subdermally. 
     
     
         34 . The method of  claim 30 , wherein the  botulinum  toxin is administered non-intramuscularly. 
     
     
         35 . The method of  claim 30 , wherein the  botulinum  toxin is administered directly. 
     
     
         36 . The method of  claim 30 , wherein the  botulinum  toxin administered further comprises a therapeutically effective amount of the  botulinum  toxin. 
     
     
         37 . The method of  claim 30 , wherein the step of administering further comprises locally administering a therapeutically effective amount of the  botulinum  toxin subdermally, non-intramuscularly to the face of a patient with the neurological disorder. 
     
     
         38 . The method of  claim 30 , wherein the neurological disorder is selected from the group consisting of seizure disorders, chronic surgical wound pain, and pain syndrome.