US 2015 0320814A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2015/0320814 A1 Patel et al. (43) Pub. Date: Nov. 12, 2015 (54) NUTRACEUTICAL FORMULATION FOR A61E36/81 (2006.01) TREATMENT OF ANXIETY AND A63L/98 (2006.01) DEPRESSION A61E36/38 (2006.01) A 6LX3/97 (2006.01) (71) Applicant: Creative Medical Health Inc., Phoenix, A61E36/28 (2006.01) AZ (US) A633/06 (2006.01) A61E36/539 (2006.01) (72) Inventors: Amit Patel, Salt Lake City, UT (US); (52) U.S. Cl. Timothy Warbington, Phoenix, AZ CPC ............... A61K 36/185 (2013.01); A61K33/06 (US); Annette Marleau, San Diego, CA (2013.01); A61 K3I/455 (2013.01); A61 K (US) 36/81 (2013.01); A61K 36/539 (2013.01); A61K 36/38 (2013.01); A61 K3I/197 (21) Appl. No.: 14/707,992 (2013.01); A61 K36/28 (2013.01); A61 K (22) Filed: May 8, 2015 31/198 (2013.01) Related U.S. Application Data (57) ABSTRACT (60) Provisional application No. 61/992,149, filed on May 12, 2014. Disclosed are compositions of matter useful for treating anxi s ety and depression. In one embodiment a nutraceutical com Publication Classification position is administered to a patient in need of said compo sition comprising of the following combination of (51) Int. Cl. ingredients: niacin, magnesium, ashwagandha, passion A6 IK36/85 (2006.01) flower, skullcap, St. John's Wort, gamma aminobutryic acid, A6 IK3 L/455 (2006.01) chamomile, and L-theanine US 2015/0320814 A1 Nov. 12, 2015 NUTRACEUTICAL FORMULATION FOR SUMMARY OF THE INVENTION TREATMENT OF ANXETY AND 0007 Embodiments herein relate to a composition for pre DEPRESSION venting and managing depression and anxiety and their CROSS-REFERENCE TO RELATED effects in a mammal comprising: niacin, magnesium, ashwa APPLICATIONS gandha, passion flower, skullcap, St. John's Wort, gamma aminobutryic acid, chamomile, and L-theanine in an amount 0001. This application claims priority to Provisional Sufficient to effect stress and anxiety in said mammal. Application Ser. No. 61/992,149, filed May 12, 2014, and 0008 Further embodiments relate to a method for reduc entitled “Nutraceutical Formulation for Treatment of Anxiety ing depression and anxiety in a mammal, said method com and Depression” which is hereby expressly incorporated by prising: identifying a mammal with stress and anxiety; reference in its entirety. administering a composition of naturally occurring Sub stances comprising niacin, magnesium, ashwagandha, pas FIELD OF THE INVENTION sion flower, skullcap, St. John's Wort, gamma aminobutryic 0002 The present technology pertains to the field of acid, chamomile, and L-theanine in an amount Sufficient to naturopathic medicine for treating depression and anxiety. effect stress and anxiety in said mammal. Specifically, the invention relates to the use of natural sub stances for management of anxiety and depression. More DETAILED DESCRIPTION specifically, the invention relates to the use of combinations 0009 Embodiments of the present invention are described of niacin, magnesium, ashwagandha, passion flower, skull below. It is, however, expressly noted that the present inven cap, St. John's Wort, gamma aminobutryic acid, chamomile, tion is not limited to these embodiments, but rather the inten and L-theanine tion is that modifications that are apparent to the person skilled in the art and equivalents thereof are also included. BACKGROUND This invention teaches compositions of natural products for 0003. Anxiety disorders and depression represent a spec the management of anxiety and depression in a mammal. One trum of disorders that cause significant psychological dis of skill in the art utilizes said formulation as a monotherapy or tress, interfering with an individual’s quality of life, produc in conjunction with treatment(s) known to address anxiety tivity and overall health status. While these disorders can be and depression. The nutraceutical formulation comprises the precipitated or exacerbated by specific environmental stres following ingredients: niacin, magnesium, ashwagandha, sors, they each also have an explicit biological basis in the passion flower, skullcap, St. John's Wort, gamma aminobu nervous system that will be reviewed briefly hereas it pertains tryic acid, chamomile, and L-theanine. to the present invention. 0010. This invention teaches compositions of natural 0004 Pharmaceuticals that have been developed to products for the management of anxiety and depression in a address these disorders include the benzodiazepines, a broad mammal. One of skill in the art utilizes said formulation as a class of drugs used to treat anxiety, insomnia, seizures, monotherapy or in conjunction with treatment(s) known to depression, panic attacks, alcohol withdrawal, and other con address anxiety and depression. The nutraceutical formula ditions. These drugs act by stimulating GABA(A) Benzodi tion comprises the following ingredients: niacin, magnesium, azepine receptors. GABA, which can be considered the ashwagandha, passion flower, skullcap, St. John's Wort, brain’s “natural valium' is the primary inhibitory neurotrans gamma aminobutryic acid, chamomile, and L-theanine mitter in the central nervous system. By acting as GABA 0011. The therapeutic properties of the various compo agonists, benzodiazepines stimulate these receptors to nents of the composition have been previously described: become more sensitive to GABA. In turn, this so-called however, utilization of these compositions in combination for “GABAergic activity” serves to and reduce excitability in the managing depression and anxiety, have not been reported. In brain whereas even a mild attenuation of GABA activity can the current invention, therapeutic complications are associ lead to arousal, anxiety, insomnia and restlessness reviewed ated with additive/synergistic effects of the named ingredi in 1. Examples of benzodiazepines include diazepam (Va.- ents to manage depression and anxiety in mammals. lium) and alprazolam (Xanax). 0012. In one embodiment, niacin is administered to a 0005. Other drugs for treating anxiety and/or depressive mammal along with a nutraceutical formulation comprising disorders include tricyclic antidepressants, monoamine oxi ashwagandha, magnesium, passion flower, skullcap, St. dase inhibitors, selective serotonin reuptake inhibitors, and John's Wort, gamma aminobutryic acid, chamomile, and serotonin and norepinephrine reuptake inhibitors. Thus, L-theanine Niacin, also known as vitamin B3 and nicotinic while GABA is a major neurotransmitter pathway in the acid, is a water-soluble B-complex vitamin that has numerous brain, drugs and/or alternative remedies for anxiety and functions in the body; for example, cholesterol metabolism, depression can also have beneficial effects by changing the production of steroid hormones in the body, and DNA repair, availability of other neurotransmitters in the brain, including and in Supporting healthy circulation and cognitive functions. serotonin, norepinephrine, and dopamine. Niacin can be acquired through dietary sources with rich food 0006 Since pharmaceuticals are not without side effects, Sources being meats, fish and prawns, peanuts, mushrooms, and the impact of herbal remedies, vitamins and minerals on seaweed, potatoes, and peas. cognitive function have been recognized for centuries, the use 0013. It has been suggested that niacin supplementation of nutraceuticals for managing anxiety and depression repre increases the availability of the mood enhancing neurotrans sent attractive alternatives. Embodiments of the present mitter serotonin through an indirect mechanism. Both niacin invention encompass compositions of matter and methods for and serotonin are biosynthesized from the amino acid L-tryp administering a nutraceutical formulation to treat anxiety and tophan in the liver. On a molar basis, approximately 60 mg of depression. dietary tryptophan is equivalent to 1 mg of niacin 2. Dietary US 2015/0320814 A1 Nov. 12, 2015 Supplementation with niacin is therefore thought to facilitate L-theanine Magnesium is an essential dietary mineral that has greater utilization of L-tryptophan toward generating seroto been used as an oral Supplement for combating depression nin. Depression is associated with low levels of serotonin, as 10. It is known in the art that magnesium deficiency causes supported by the beneficial effects of a class of drugs known neuropathologies, possibly due to its role in neuronal signal as selective serotonin uptake inhibitors such as Prozac. Niacin transduction. A published report Summarizing case histories is a natural alternative to prescription drugs for treatment of revealed that magnesium deficiency is accompanied by a anxiety and depression. In its most severe form, niacin defi spectrum of cognitive defects, including anxiety, insomnia, ciency causes pellagra, a disease that resembles Schizophre irritability, postpartum depression, and short tem memory nia that is marked by impaired by disturbances in psychosen loss 11. Rapid recovery from major depression can be sory, psychomotor, and emotional functions 3. Depression afforded by supplementation of patients with 125-300 mg of that is associated with pellagra is attributed to deficiency of magnesium with each meal and at bedtime. In one embodi serotonin in the brain, resulting from decreased availability of ment of the present invention, magnesium is administered to tryptophan. In an early report (1953), 14 of 15 patients with an individual Suffering from depression and/or anxiety at clinical depression treated with nicotinic acid showed