COMPOSITIONS AND METHODS FOR TREATING DEPRESSION

Abstract

Disclosed are a novel combination of specific therapeutics selected from S-adenosyl methionine or a salt thereof, folic acid or a metabolite or salt thereof, and one or more omega-3 fatty acids or salts thereof, useful for a variety of conditions, as discussed herein. Methods of treatment include the treatment of neuropsychiatric conditions, such as depression.

Claims

1-103. (canceled)

104. A method for improving or stabilizing mood of a subject comprising administering to the subject: S-adenosyl methionine or a salt thereof; methyl folate or a salt thereof; and one or more omega-3 fatty acids or salts thereof, wherein the one or more omega-3 fatty acids or salts thereof comprises at least 60% eicosapentaenoic acid (EPA) or a salt thereof.

105. The method of claim 104, wherein the S-adenosyl methionine or salt thereof is administered in an amount from 200 mg to 4000 mg, inclusive.

106. The method of claim 104, wherein the S-adenosyl methionine or salt thereof is administered in an amount from 800 mg to 1600 mg, inclusive.

107. The method of claim 104, wherein the methyl folate or salt thereof is administered in an amount from 1 mg to 45 mg, inclusive.

108. The method of claim 104, wherein the methyl folate or salt thereof is administered in an amount from 5 mg to 20 mg, inclusive.

109. The method of claim 104, wherein the one or more omega-3 fatty acids or salts thereof is administered in an amount from 500 mg to 5000 mg, inclusive.

110. The method of claim 104, wherein the one or more omega-3 fatty acids or salts thereof is administered in an amount from 800 mg to 1600 mg, inclusive.

111. The method of claim 104, wherein the one or more omega-3 fatty acids or salts thereof are selected from EPA, docosahexaenoic acid (DHA), and combinations thereof.

112. The method of claim 104, wherein: the S-adenosyl methionine or salt thereof is administered in an amount from 200 mg to 4000 mg, inclusive; the methyl folate or salt thereof is administered in an amount from 1 mg to 45 mg, inclusive; and the one or more omega-3 fatty acids or salts thereof is administered in an amount from 500 mg to 5000 mg, inclusive.

113. The method of claim 104, wherein: the S-adenosyl methionine or salt thereof is administered in an amount from 800 mg to 1600 mg, inclusive; the methyl folate or salt thereof is administered in an amount from 5 mg to 20 mg, inclusive; and the one or more omega-3 fatty acids or salts thereof is administered in an amount from 800 mg to 1600 mg, inclusive.

114. The method of claim 104, wherein the subject is a human.

115. The method of claim 104, wherein the subject has Major Depressive Disorder.

116. The method of claim 104, wherein the subject does not have Major Depressive Disorder.

117. The method of claim 104 further comprising administering vitamin B.sub.12 to the subject.

118. The method of claim 104 further comprising administering vitamin E to the subject.

119. The method of claim 104, wherein one or more of the S-adenosyl methionine or salt thereof, methyl folate or salt thereof, and one or more omega-3 fatty acids or salts thereof are present in a composition comprising vitamin E.

120. A method for improving cognition in a subject comprising administering to the subject: S-adenosyl methionine or a salt thereof; methyl folate or a salt thereof; and one or more omega-3 fatty acids or salts thereof, wherein the one or more omega-3 fatty acids or salts thereof comprises at least 60% eicosapentaenoic acid (EPA) or a salt thereof.

121. The method of claim 120, wherein the subject has dementia.

122. The method of claim 120, wherein the subject does not have dementia.

123. A method for promoting happiness and/or reducing depressive symptoms in a subject comprising administering to the subject: S-adenosyl methionine or a salt thereof; methyl folate or a salt thereof; and one or more omega-3 fatty acids or salts thereof, wherein the one or more omega-3 fatty acids or salts thereof comprises at least 60% eicosapentaenoic acid (EPA) or a salt thereof.

124. The method of claim 123, wherein the subject does not meet the clinical criteria for Major Depressive Disorder and/or does not meet the clinical criteria for treatment with a prescription anti-depressant.

Description

EXAMPLES

[0250] In order that the invention described herein may be more fully understood, the following examples are set forth. It should be understood that these examples are for illustrative purposes only and are not to be construed as limiting this invention in any manner.

Example 1

[0251] Provided below is a therapy formulated for oral administration to be taken orally 1 to 3 times daily. One or more of the below listed therapeutics can be formulated together in the same composition, or formulated in separate compositions.

TABLE-US-00002 Therapeutic Dosage SAMe 800 mg Folic acid 1 mg Omega-3 fatty acids or salts thereof (EPA 50% min.) 1.0 g Vitamin B.sub.12 500 μg

Example 2

[0252] Provided below is a therapy formulated for oral administration to be taken orally 2 to 4 times daily. One or more of the below listed therapeutics can be formulated together in the same composition, or formulated in separate compositions.

TABLE-US-00003 Therapeutic Dosage SAMe 400 mg Folic acid 1 mg Omega-3 fatty acids or salts thereof (EPA 50% min.) 1.0 g

Example 3

[0253] Provided below are therapies formulated for oral administration to be taken orally 1 to 3 times daily. One or more of the below listed therapeutics can be formulated together in the same composition, or formulated in separate compositions.

Therapy comprising 7.5 mg of L-methylfolate calcium salt:

TABLE-US-00004 Therapeutic Dosage SAMe 800 mg 1600 mg  800 mg 1600 mg 800 mg L-methylfolate  7.5 mg  7.5 mg  7.5 mg   7.5 mg  7.5 mg calcium salt Omega-3 fatty 600 mg 600 mg 1200 mg  1200 mg 600 mg acids or salts thereof (EPA 50% min.) Vitamin B.sub.12 — — — — 500 μg
Therapy comprising 10 mg of L-methylfolate calcium salt:

TABLE-US-00005 Therapeutic Dosage SAMe 800 mg 1600 mg  800 mg 1600 mg 800 mg L-methylfolate  10 mg  10 mg  10 mg  10 mg  10 mg calcium salt Omega-3 fatty 800 mg 800 mg 1200 mg  1200 mg 800 mg acids or salts thereof (EPA 50% min.) Vitamin B.sub.12 — — — — 500 μg
Therapy comprising 15 mg of L-methylfolate calcium salt:

TABLE-US-00006 Therapeutic Dosage SAMe 800 mg 1600 mg  800 mg 1600 mg 800 mg L-methylfolate  15 mg  15 mg  15 mg  15 mg  15 mg calcium salt Omega-3 fatty 800 mg 800 mg 1200 mg  1200 mg 800 mg acids or salts thereof (EPA 50% min.) Vitamin B.sub.12 — — — — 500 μg
Therapy comprising 20 mg of L-methylfolate calcium salt:

TABLE-US-00007 Therapeutic Dosage SAMe 800 mg 1600 mg  800 mg 1600 mg 800 mg L-methylfolate  20 mg  20 mg  20 mg  20 mg  20 mg calcium salt Omega-3 fatty 800 mg 800 mg 1200 mg  1200 mg 800 mg acids or salts thereof (EPA 50% min.) Vitamin B.sub.12 — — — — 500 μg

OTHER EMBODIMENTS

[0254] All patents, patent applications, and literature references cited herein are incorporated herein by reference.

[0255] The foregoing has been a description of certain non-limiting embodiments of the invention. Those of ordinary skill in the art will appreciate that various changes and modifications to this description may be made without departing from the spirit or scope of the present invention, as defined in the following claims.