IP Library › Granted Patent US 11,110,113
Granted Patent B2
US 11,110,113 · App. 16/347,156 · Granted Sep 7, 2021

Compositions and methods for treating depression

Inventor: Alexander Vuckovic (Carlisle, MA)
Assignee: Gentelon, Inc.
A61K31/7076A61K31/202A61K31/519A61K31/593A61K31/685
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Quick Facts
Patent No.
US 11,110,113
App. No.
16/347,156
Granted
Sep 7, 2021
Kind
B2
Abstract

Disclosed is a therapeutic regimen which includes S-adenosyl methionine, or a salt thereof; folic acid, or a metabolite therof, or a salt thereof; and a compound of Formula (I), or salt thereof, useful in the treatment of a variety of conditions, e.g., neuropsychiatric conditions such as depression. The therapeutic regimen may be used in combination with therapeutic agents as described here.

Claims (26)

1. A method of treating a neuropsychiatric condition, or for promoting wellness and/or energy, the method comprising administering an effective amount of S-adenosyl methionine (SAMe), or a salt thereof; methyl folate, or a salt thereof; and a compound of Formula (I):

or a salt thereof, wherein:

R is hydrogen or —C(═O)R A , wherein R A is unsubstituted C 10-18 alkyl; and

—C(═O)R B is of the formula:

to a subject in need thereof.

2. The method of claim 1 , wherein the compound of Formula (I) is of the formula:

or a salt thereof.

3. The method of claim 1 , wherein the compound of Formula (I), or salt thereof, is provided in a range of between about 50 mg to about 1000 mg, inclusive.

4. The method of claim 1 , wherein S-adenosyl methionine, or a salt thereof, is provided in a range of between about 200 mg to about 2000 mg, inclusive.

5. The method of claim 1 , wherein methyl folate, or a salt thereof, is provided in a range of between about 1 mg to about 45 mg, inclusive.

6. The method of claim 1 , further comprising administering one or more omega-3 fatty acids, or salts thereof.

7. The method of claim 6 , wherein one or more omega-3 fatty acids, or salts thereof, is provided in a range of between about 500 mg to about 5 g, inclusive.

8. The method of claim 6 , wherein the one or more omega-3 fatty acids, or salts thereof, comprises at least 50% EPA.

9. The method of claim 1 , further comprising administering vitamin D3.

10. The method of claim 9 , wherein the vitamin D3 is provided in a range of about 500 IU to about 2000 IU, inclusive.

11. The method of claim 1 , further comprising administering vitamin B 12.

12. The method of claim 1 , wherein S-adenosyl methionine (SAMe), or a salt thereof; methyl folate, or a salt thereof; and a compound of Formula (I), or a salt thereof, are each administered separately in different compositions.

13. The method of claim 1 , wherein S-adenosyl methionine (SAMe), or a salt thereof; methyl folate, or a salt thereof; and a compound of Formula (I), or a salt thereof, are administered together in the same composition.

14. The method of claim 1 , wherein the neuropsychiatric condition is selected from mood disorders or conditions characterized by atypical mood.

15. The method of claim 14 , wherein the mood disorders are selected from the group consisting of depression, Bipolar Disorder, and Anxiety Disorder.

16. The method of claim 15 , wherein the depression is Major Depressive Disorder.

17. The method of claim 14 , wherein the condition characterized by atypical mood is selected from the group consisting of stress, hormonal mood swings, Mild Cognitive Impairment, substance-induced mood disorders, dementia, Alzheimer's disease, Parkinson's disease, Huntington's disease, and psychotic disorders.

18. The method of claim 17 , wherein the hormonal mood swings are mood swings during pregnancy, during post-partum, during puberty, or during menopause, or are a result of a Premenstrual Dysphoric Disorder condition.

19. The method of claim 17 , wherein the psychotic disorder is selected from the group consisting of Schizoaffective Disorder, Schizophrenia, Delusional Disorder, and Psychotic Disorder Not Otherwise Specified.

20. The method of claim 1 , wherein the method is for treating depression.

21. The method of claim 1 , wherein the compound of Formula (I), or salt thereof, is provided in a range of between about 100 mg to about 500 mg, inclusive.

Assignments (3)
CHANGE OF NAME Recorded Dec 2, 2022
From: GENTELON, INC.
To: HEDONIAUSA, INC.
Reel/Frame 062052/0633 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 5, 2021
From: ALEXANDER VUCKOVIC, M.D., LLC
To: GENTELON, INC.
Reel/Frame 055164/0031 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 5, 2019
From: VUCKOVIC, ALEXANDER
To: ALEXANDER VUCKOVIC, M.D., LLC
Reel/Frame 049953/0153 →
Continuity (2)
Provisional Application 62417229 · Nov 3, 2016
Related Publication 20200179429A1 · Jun 11, 2020