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 grouop consisting of: transdermal injection; a subcutaneous injection; and a percutaneous injection; and thereby reducing at least one symptom of anxiety disorder.

1 . A method for simultaneously treating both a sleep disorder and an anxiety disorder in a subject in need thereof, the method comprising the steps of:
 identifying a subject with both a sleep disorder and an anxiety disorder; and   (ii) administering an effective amount of a composition comprising a  botulinum  toxin immunotype A and a pharmaceutically acceptable carrier to the subject,   thereby reducing at least one symptom of both the sleep disorder and the anxiety disorder in the subject;   wherein the sleep disorder is sleep onset insomnia or sleep maintenance insomnia.   
     
     
         2 . The method of  claim 1 , wherein the  botulinum  toxin is  botulinum  toxin of immunotype A from the Hall strain of  Clostridium botulinum.    
     
     
         3 . The method of  claim 1 , wherein the administration comprises injection. 
     
     
         4 . The method of  claim 1 , wherein the  botulinum  toxin is administered to one or more of the subject's scalp, forehead, face, or periocular region. 
     
     
         5 . The method of  claim 1 , wherein the  botulinum  toxin is administered to the neck. 
     
     
         6 . The method of  claim 1 , wherein the  botulinum  toxin is in an amount sufficient to cross the blood brain barrier. 
     
     
         7 . The method of  claim 6 , wherein said composition decreases choline acetyltransferase activity. 
     
     
         8 . The method of  claim 3 , wherein the administration comprises injection at multifocal sites. 
     
     
         9 . The method of  claim 1 , wherein the  botulinum  toxin is administered in an amount from 1.25 units to 3,000 units of  botulinum  toxin. 
     
     
         10 . The method of  claim 1 , wherein the composition further comprises a polycationic protein. 
     
     
         11 . The method of  claim 1 , wherein the composition further comprises hyaluronidase. 
     
     
         12 . The method of  claim 1 , wherein the  botulinum  toxin is administered to an extra cranial region of soft tissue. 
     
     
         13 . The method of  claim 1 , wherein the  botulinum  toxin is administered to at least one of the nasal cavities and the sinus cavities of the subject. 
     
     
         14 . The method of  claim 1 , further comprises determining a level of glutamate neurotransmission in the brain of the subject. 
     
     
         15 . The method of  claim 1 , further comprising the step of testing the subject for elevated glutamate levels, wherein an elevated level of glutamate neurotransmission in the brain is an attribute of anxiety disorder. 
     
     
         16 . The method of  claim 1 , wherein the at least one symptom related to the anxiety disorder comprises nausea, dizziness, fear, diarrhea, fatigue, sleep disorder, panic attacks, hyperventilation, chills, hot flashes, or fast pulse. 
     
     
         17 . The method of  claim 1 , wherein the anxiety disorder comprises a generalized anxiety disorder. 
     
     
         18 . The method of  claim 1 , wherein the anxiety disorder comprises a post-traumatic stress disorder. 
     
     
         19 . The method of  claim 1 , further comprising the step of testing a subject for elevated acetylcholine levels, wherein an elevated level of acetylcholine neurotransmission in the brain is an attribute of an anxiety disorder. 
     
     
         20 . The method of  claim 9 , wherein the amount of  botulinum  toxin in the composition administered is approximately 100 units. 
     
     
         21 . The method of  claim 6 , wherein the composition further comprises a polycationic protein. 
     
     
         22 . The method of  claim 6 , wherein the composition further comprises hyaluronidase. 
     
     
         23 . The method of  claim 1 , wherein the composition does not contain human blood products. 
     
     
         24 . The method of  claim 3 , wherein the injection is transcutaneous, subcutaneous, transdermal, or intramuscular injection. 
     
     
         25 . The method of  claim 1 , wherein the  botulinum  toxin is administered to the subject in tissues areas that enhance venous drainage from the site of administration to the central nervous system or that enhance uptake by the portal hypophyseal drainage system.