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

Abstract

A method of treating anxiety disorder comprising the steps of: identifying a subject with one or more symptoms of an anxiety disorder; a botulinum toxin to soft tissues outside the neurocranium using an injection selected from the group consisting of: a transdermal injection; a subcutaneous injection; and a percutaneous injection; and thereby reducing at least one symptom of anxiety disorder.

1 .- 9 . (canceled) 
     
     
         10 . A method of treating anxiety comprising the steps of: or identifying a subject with at least one symptom of an anxiety disorder; and administering an effective amount of a composition comprising a botulinum toxin to soft tissue outside a neurocranium of said subject using at least one of: a transdermal injection, a subcutaneous injection, an osseous injection and a percutaneous injection delivering at least a portion of the botulinum toxin to a central nervous system of said subject, thereby reducing at least one symptom of anxiety. 
     
     
         11 . The method of  claim 10 , wherein the botulinum toxin is immunotype A, B, C, D, E, F, or G. 
     
     
         12 . The method of  claim 10 , wherein the botulinum toxin is botulinum toxin type A from Hall strain  Clostridium botulinum.    
     
     
         13 .- 14 . (canceled) 
     
     
         15 . The method of  claim 10 , wherein the injection is multifocal. 
     
     
         16 . (canceled) 
     
     
         17 . The method of  claim 10 , wherein the composition is administered to at least one of: a scalp, a face, and a per-ocular region of the subject. 
     
     
         18 . The method of  claim 10 , wherein the composition is administered to the neck. 
     
     
         19 .- 60 . (canceled) 
     
     
         61 . A method of treating an anxiety disorder comprising the steps of: identifying a subject with one or more symptoms of an anxiety disorder; administering to at least one soft tissue region outside a neurocranium of said subject a composition comprising a botulinum neurotoxin wherein said composition is diffused across a blood brain barrier in an amount sufficient to at least one central nervous system neurotransmitter comprising at least one of: glutamate, acetylcholine, GABA, nor epinephrine and corresponding receptors. 
     
     
         62 . The method of  claim 61 , wherein said composition decreases choline acetyltransferase activity. 
     
     
         63 .- 64 . (canceled) 
     
     
         65 . The method of claim  64 , wherein said botulinum neurotoxin is immunotype A, B, C, D, E, F, or G. 
     
     
         66 .- 67 . (canceled) 
     
     
         68 . The method of  claim 61 , wherein the step of administering further comprises a plurality of multifocal injections. 
     
     
         69 .- 70 . (canceled) 
     
     
         71 . The method of  claim 61 , wherein the composition is administered to at least one of a neck, a scalp, a face, and a per-ocular region of the subject. 
     
     
         72 .- 115 . (canceled) 
     
     
         116 . The method of  claim 10 , wherein an amount of the composition administered to the soft tissue is greater than 5 units and less than 3,000 units. 
     
     
         117 . The method of  claim 10 , further comprising the step of preparing the botulinum toxin with polycationic protein. 
     
     
         118 . The method of  claim 10 , further comprising the step of preparing the botulinum toxin with hyaluronidase. 
     
     
         119 . The method of  claim 10 , wherein a location of the soft tissue is extra cranial. 
     
     
         120 . The method of  claim 10 , wherein the step of administering the botulinum toxin further comprises injecting the botulinum toxin into at least one of the nasal cavities and the sinus cavities. 
     
     
         121 . The method of  claim 10 , further comprising the step of determining a level of at least one of glutamate neurotransmission, glutamate content, and corresponding receptors in the brain of the subject, wherein an elevated level of glutamate neurotransmission in the brain is an attribute of anxiety disorder. 
     
     
         122 . The method of  claim 10 , further comprising the step of testing a subject for elevated glutamate levels, wherein an elevated level of at least one of glutamate content and receptors and corresponding glutamate neurotransmission in the brain is an attribute of anxiety disorder. 
     
     
         123 . The method of  claim 61 , wherein the step of identifying a subject with one or more symptoms of a anxiety disorder further comprises determining a level of glutamate neurotransmission in the brain of the subject. 
     
     
         124 . The method of  claim 61 , further comprising the step of testing a subject for elevated glutamate levels, wherein an elevated level of glutamate neurotransmission in the brain is an attribute of anxiety disorder. 
     
     
         125 . The method of  claim 10 , wherein the at least one symptom further comprises at least one of: nausea, dizziness, fear, abdominal pain, depression, diarrhea, fatigue, sleep disorder, chest pain, panic attacks, hyperventilation, diffuse muscle aches, chills, hot flashes, and fast pulse. 
     
     
         126 . The method of  claim 10 , wherein the anxiety disorder further comprises a generalized anxiety disorder. 
     
     
         127 . The method of  claim 10 , wherein the anxiety disorder further comprises a post-traumatic stress disorder. 
     
     
         128 . A method of suppressing central nervous system neurotransmission with the central nervous system in a mammal comprising:
 injecting a botulinum toxin composition into a soft tissue region outside the neurocranium;   diffusing at least a portion of the botulinum toxin composition across the blood brain barrier, wherein the portion of the botulinum toxin composition reaches the central nervous system; and   blocking at least one neurotransmitter.   
     
     
         129 . The method of  claim 128 , wherein the neurotransmitter is a glutamate receptor. 
     
     
         130 . The method of  claim 128 , wherein the neurotransmitter is an acetylcholine receptor. 
     
     
         131 . The method of  claim 128 , further comprising the step of testing a subject for elevated glutamate levels, wherein an elevated level of glutamate neurotransmission in the brain is an attribute of anxiety disorder. 
     
     
         132 . The method of  claim 128 , wherein an amount of the botulinum toxin administered to the soft tissue is greater than 2.5 units and less than 3,000 units. 
     
     
         133 . The method of  claim 128 , wherein the step of injecting further comprises a plurality of multifocal injections. 
     
     
         134 . Method of  claim 116 , wherein the amount of the composition administered is approximately 100 units. 
     
     
         135 . A method of treating a psychological trauma disorder in a mammal characterized as post-traumatic stress syndrome, the method comprising the steps of administering to the mammal a therapeutically effective amount of a composition including botulinum neurotoxin to at least one of the extra cranial regions of the head and neck wherein the administration of the composition reduces a symptom of the psychological trauma disorder. 
     
     
         136 . The method of  claim 135 , wherein an amount of the composition administered to the soft tissue is greater than 5 units and less than 3,000 units. 
     
     
         137 . The method of  claim 136 , wherein the amount of the composition administered is approximately 100 units. 
     
     
         138 . The method of  claim 135 , wherein the administration of the composition mitigates anger, nightmares and flashbacks. 
     
     
         139 . The method of  claim 135 , wherein the administration of the composition mitigates depression associated with post-traumatic stress syndrome. 
     
     
         140 . The method of  claim 135 , wherein the administration of the composition mitigates depression and anxiety associated with post-traumatic stress syndrome.