Composition and method for treatment of depression and psychosis in humans

• US 9,486,453 B2
• Filed: 09/03/2015
• Issued: 11/08/2016
• Est. Priority Date: 07/12/2012
• Status: Active Grant

• Current Assignee: Glytech, LLC
• Original Assignee: Glytech, LLC
• Inventors: Javitt, Daniel C.
• Primary Examiner(s): BARSKY, JARED
• Application Number:
  US14/844,021
• Publication Number:
  US 20150374684A1
• Time in Patent Office: 432 Days
• Field of Search: None
• 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 reducing akathisia caused by lurasidone treatment in a subject with bipolar disorder, comprising:

administering an akathisia-inducing amount of lurasidone to the subject;

once akathisia is induced, continuing to administer lurasidone at a same dosage and frequency that caused akathisia; and

administering a therapeutically effective amount of a second composition comprising D-cycloserine (DCS) at a dosage in excess of 500 mg/day, wherein the DCS produces a NMDA receptor antagonistic blood plasma concentration measured at greater than 25 micrograms/mL,

thereby reducing akathisia.

3. The method of claim 1, wherein the lurasidone and second composition are administered intramuscularly, intravenously, intraperitoneally, parentally, or orally.

5. The method of claim 1, wherein the wherein the lurasidone and second composition are formulated as a single composition for administration to the subject.

2. A method for reducing the incidence of akathisia caused by lurasidone treatment in a subject with bipolar disorder, comprising:

administering therapeutically effective amounts of lurasidone, ketamine, and D-cycloserine (DCS) to a subject with bipolar disorder, wherein DCS is administered at a dosage in excess of 500 mg/day,

wherein the DCS produces a NMDA receptor antagonistic blood plasma concentration measured at greater than 25 micrograms/mL, thereby reducing the incidence of akathisia caused by lurasidone.

4. The method of claim 2, wherein the lurasidone, ketamine, and D-cycloserine (DCS) are administered intramuscularly, intravenously, intraperitoneally, parentally, or orally.

6. The method of claim 2, wherein the wherein the lurasidone, ketamine, and D-cycloserine (DCS) are formulated as a single composition for administration to the subject.