COMPOSITION AND METHOD FOR TREATMENT OF DEPRESSION AND PSYCHOSIS IN HUMANS

• US 20150374684A1
• Filed: 09/03/2015
• Published: 12/31/2015
• Est. Priority Date: 07/12/2012
• Status: Active Grant

• Current Assignee: Glytech, LLC
• Original Assignee: Glytech, LLC
• Inventors: Javitt, Daniel C.
• Granted Patent: US 9,486,453 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/06 the aromatic ring being substituted by nitro groups
• CPC Class Codes: A61K 31/135 having aromatic rings , e.g. ketamine, nortriptyline methadone A61K31/137
• CPC Class Codes: A61K 31/138 Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377
• CPC Class Codes: A61K 31/381 having five-membered rings
• CPC Class Codes: A61K 31/42 Oxazoles
• CPC Class Codes: A61K 31/431 containing further heterocyclic rings, e.g. ticarcillin, azlocillin, oxacillin
• CPC Class Codes: A61K 31/4525 containing a five-membered ring with oxygen as a ring hetero atom
• CPC Class Codes: A61K 31/496 Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 31/55 having seven-membered rings, e.g. azelastine, pentylenetetrazole
• CPC Class Codes: A61K 31/551 having two nitrogen atoms, e.g. dilazep
• CPC Class Codes: A61K 31/553 having at least one nitrogen and one oxygen as ring hetero atoms, e.g. loxapine, staurosporine
• CPC Class Codes: A61K 31/554 having at least one nitrogen and one sulfur as ring hetero atoms, e.g. clothiapine, diltiazem
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/18 Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Compositions and methods for the treatment of depression and psychoses in humans are disclosed. More particularly, the invention is directed to formulations containing antipsychotic and/or antidepressant medications and also containing an NMDAR antagonist. The present Invention Is also directed to methods tor the treatment of humans suffering from depression and other psychoses, including, schizophrenia, by administration of the inventive compositions in antidepressant and/or antipsychotic effective amounts.

Claims

1. A method for the treatment of a condition in a human subject selected from the group consisting of depression and suicidality, the method comprising:

administering to the human subject an anti-depression or anti-suicidality effective amount of;

a first compound comprising lurasidone; and

a second compound comprising D-cycloserine (DCS) administered at a dose in excess of 500 mg/day, wherein the DCS produces a blood plasma concentration of greater than 25 μ

g/mL,

thereby treating the condition.

2. The method of claim 1, wherein the condition is associated with bipolar disorder.

3. The method of claim 1, wherein the condition is associated with a symptom selected from the group consisting of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, and akathisia.

4. The method of claim 1, further comprising administering to the human subject a third compound comprising ketamine.

5. The method of claim 1, wherein the first and second compounds are administered intramuscularly, intravenously, intraperitoneally, parentally, or orally.

6. The method of claim 4, wherein the first, second, and third compounds are administered intramuscularly, intravenously, intraperitoneally, parentally, or orally.

7. The method of claim 1, wherein the first and second compounds are formulated as a single composition for administration to the human subject.

8. The method of claim 4, wherein the first, second, and third compounds are formulated as a single composition for administration to the human subject.

9. The method of claim 1, wherein the condition is depression.

10. The method of claim 1, wherein the condition is suicidality.

11. The method of claim 10, wherein the suicidality is suicidal ideation and behavior.