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

Abstract

A method of treating major depression comprising the steps of: identifying a subject with one or more symptoms of a depressive disorder; and administering 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 depression.

1 . A method of treating major depression comprising the steps of: identifying a subject with one or more symptoms of a depressive disorder; administering 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 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. 
     
     
         4 - 5 . (canceled) 
     
     
         6 . The method of  claim 1 , wherein the injection is multifocal. 
     
     
         7 . (canceled) 
     
     
         8 . The method of  claim 1 , wherein the botulinum toxin is administered to the scalp. 
     
     
         9 . The method of  claim 1 , wherein the botulinum toxin is administered to the neck. 
     
     
         10 - 15 . (canceled) 
     
     
         16 . The method of  claim 1 , wherein the botulinum toxin is administered to at least one of the face, the per-ocular region, and the forehead. 
     
     
         17 - 27 . (canceled) 
     
     
         28 . The method of  claim 1 , wherein at least one of the symptoms of a depressive disorder is insomnia. 
     
     
         29 - 38 . (canceled) 
     
     
         39 . A method of suppressing central nervous system neurotransmission in a mammal, comprising the steps of identifying a subject with at least one symptom of a central nervous system disorder and administering a composition comprising a botulinum toxin at least one soft tissue region of said subject outside the neurocranium in an amount sufficient to diffuse said neurotoxin across the blood brain barrier resulting in suppression of at least one neurotransmitter. 
     
     
         40 . (canceled) 
     
     
         41 . The method of  claim 39 , wherein said at least one neurotransmitter is acetylcholine. 
     
     
         42 - 45 . (canceled) 
     
     
         46 . The method of  claim 39 , wherein the injection is multifocal. 
     
     
         47 - 115 . (canceled) 
     
     
         116 . The method of  claim 1 , wherein an amount of the botulinum toxin administered to the soft tissue is greater than 5 units and less than 3,000 units. 
     
     
         117 . The method of  claim 1 , further comprising the step of preparing the botulinum toxin with polycationic protein. 
     
     
         118 . The method of  claim 1 , further comprising the step of preparing the botulinum toxin with hyaluronidase. 
     
     
         119 . The method of  claim 1 , wherein a location of the soft tissue is extra cranial. 
     
     
         120 . The method of  claim 1 , 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 1 , further comprising the step of determining a level of glutamate neurotransmission in the brain of the subject, wherein an elevated level of glutamate neurotransmission in the brain is an attribute of major depression. 
     
     
         122 . The method of  claim 1 , further comprising the step of testing a subject for elevated glutamate levels, wherein an elivated level of glutamate neurotransmission in the brain is an attribute of major depression. 
     
     
         123 . The method of  claim 39 , wherein the neurotransmitter is glutamate. 
     
     
         124 . The method of  claim 39 , wherein the step of identifying a subject with one or more symptoms of a central nervous system disorder further comprises determining a level of glutamate neurotransmission in the brain of the subject. 
     
     
         125 . The method of  claim 39 , 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 central nervous system disorder. 
     
     
         126 . A method of providing neuroprotection to the brain comprising the steps of:
 identifying a subject with at least one symptom of a central nervous system disorder; and   administering a composition comprising a botulinum to said subject outside a neurocranium of the subject in an amount sufficient to reduce neuronal cell loss in at least one portion of the central nervous system by suppressing at least one neurotransmitter that exhibits neurotoxic activity.   
     
     
         127 . The method of  claim 126 , wherein the neurotransmitter further comprises glutamate. 
     
     
         128 . The method of  claim 126 , wherein the central nervous system disorder further comprises neurodegenerative disease. 
     
     
         129 . The method of  claim 126 , wherein the central nervous system disorder further comprises Alzheimer's disease. 
     
     
         130 . The method of  claim 126 , wherein the central nervous system disorder further comprises Huntington's disease. 
     
     
         131 . The method of  claim 126 , wherein the central nervous system disorder further comprises generalized seizures. 
     
     
         132 . The method of  claim 126 , wherein the central nervous system disorder further comprises Parkinson's disease. 
     
     
         133 . The method of  claim 126 , wherein the central nervous system disorder further comprises schizophrenia. 
     
     
         134 . The method of  claim 126 , wherein the central nervous system disorder further comprises a cerebral vascular disease. 
     
     
         135 . The method of  claim 126 , wherein the central nervous system disorder further comprises a stroke. 
     
     
         136 . The method of  claim 126 , wherein the central nervous system disorder further comprises dementia. 
     
     
         137 . The method of  claim 126 , wherein the botulinum toxin is immunotype A, B, C, D, E, F, or G. 
     
     
         138 . The method of  claim 126 , wherein an amount of the botulinum toxin administered is greater than 5 units and less than 3,000 units. 
     
     
         139 . The method of  claim 126 , further comprising the step of preparing the botulinum toxin with hyaluronidase. 
     
     
         140 . The method of  claim 126 , further comprising the step of preparing the botulinum toxin with albumin. 
     
     
         141 . The method of  claim 126 , further comprising the step of preparing the botulinum toxin without human blood products. 
     
     
         142 . The method of  claim 126 , wherein the step of administering the composition further comprises intramuscular administration of the composition. 
     
     
         143 . The method of  claim 126 , wherein the step of administering the composition further comprises an injection selected from the group consisting of: a transdermal injection; a subcutaneous injection; and a percutaneous injection. 
     
     
         144 . The method of  claim 126 , wherein the step of administering the composition further comprises topical administration of the composition. 
     
     
         145 . The method of  claim 39 , wherein the central nervous system disorder further comprises at least one of: major depression, bipolar disease, mania, generalized anxiety, neurosis, chronic insomnia, post-traumatic stress syndrome, Alzheimer's disease, Parkinson's disease, Huntington's disease, Attention Deficit Syndrome, obsessive compulsive conditions and disorders, phobias, chronic seizure disorders including generalized, focal motor, partial complex), chronic agitation, dementia, vascular accidents and stroke, circadian rhythm disorders, and mental retardation. 
     
     
         146 . The method of  claim 1 , wherein the quantity is sufficient to suppress at least one centrally acting neurotransmitter. 
     
     
         147 . A method of lowering a level of glutamate neurotransmission in the brain of a subject comprising injecting the subject with botulinum toxin in at least one soft tissue area comprising the head and neck.