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.

Description

[0001]This application claims benefit to U. S. Provisional Application Ser. No. 60 / 690,162, filed on Jun. 14, 2005; U. S. Provisional Application Ser. No. 60 / 693,771, filed on Jun. 27, 2005; U. S. Provisional Application Ser. No. 60 / 721,060, filed on Sep. 28, 2005; U. S. Provisional Application Ser. No. 60 / 738,981, filed on Nov. 23, 2005, all of which are hereby incorporated herein by reference in their entireties.FIELD OF THE INVENTION[0002]The present invention relates to the treatment of primary disorders of mood and affect with a neurotoxin, including depressive, anxiety and sleep disorders as well as other CNS disorders.BACKGROUND OF THE INVENTION[0003]Depression is one of the most prevalent and pervasive forms of mental illness that affects individuals across age and gender lines. (Gainotti et al. (2001) J. Neural Neurosurg. Psychiatr. 71: 258-261; Wong et al. (2001) Nature Rev. Neurosci. 2: 343-351; Nestler et al. (2002) Neuron 34: 13-25). The lifetime risk of major depressio...

AI Technical Summary

Benefits of technology

The invention provides methods for treating anxiety disorders by delivering a neurotoxin to the central nervous system of a subject. This decreases the transmission of neurotransmitters such as glutamate, nor-epinephrine, or acetyl-choline, which are associated with anxiety. The methods can be administered through injection or topical application, and can help reduce symptoms associated with degenerative diseases associated with inflammation.

Problems solved by technology

Major depression is a particularly disabling and pernicious, in part, because it is recurring.

As a consequence of numerous dietary restrictions associated with the use of monoamine oxidase inhibitors, extensive side effects, including hypertension, headache, myoclonic jerk, sleep disruption, and gastrointestinal complications, monoamine oxidase inhibitors are currently not used as a first-line antidepressant.

Although generally milder than the monoamine oxidase inhibitors and the tricyclic antidepressants, SSRIs also produce numerous side effects.

Direct injection into the brain is not practical and in fact unlikely to be conventionally practiced by a physician skilled in the treatment of seizure disorders because of the possibility and risk associated with induced hemorrhage, scarring, neuronal loss and placement difficulty, infection (meningitis) and inconvenience associated with necessary delivery mechanisms.

Direct injection into the CNS is highly impractical because of such complications associated with invasive intracranial procedures.

Despite this suggestion, controlled trials using small numbers of patients in the study groups, have failed to demonstrate the efficacy of botulinum toxin for the treatment of myofascial and other forms of pain.

The ineffectiveness of botulinum toxin to treat a variety of pain syndromes, in controlled trial, has been attributed to small sample size and relatively low statistical power.

The statistical significance of these results, however, was uncertain, inconsistent between treatment groups, and exhibited unexplained inverted dose response curves.

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