Dosage regimen, medication dispensing package and uses thereof for the treatment of major depressive disorder

• US 9,789,093 B2
• Filed: 01/30/2012
• Issued: 10/17/2017
• Est. Priority Date: 01/31/2011
• Status: Active Grant

• Current Assignee: Sarah Herzog Memorial Hospital Ezrat Nashim Association
• Original Assignee: Serotech, LLC
• Inventors: Heresco-Levy, Uriel, Javitt, Daniel
• Primary Examiner(s): Hui, San-Ming
• Application Number:
  US13/982,460
• Publication Number:
  US 20140018349A1
• Time in Patent Office: 2,087 Days
• Field of Search: 514596
• 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 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/42 Oxazoles
• 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 31/551 having two nitrogen atoms, e.g. dilazep
• CPC Class Codes: A61K 31/5513 1,4-Benzodiazepines, e.g. diazepam or clozapine
• 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 25/24 Antidepressants

Abstract

This invention provides an oral dosage regimen for the treatment of depression, a pharmaceutically acceptable medication dispensing package containing multiple dosage units of medicaments comprising an oral dosage regimen of D-cycloserine for the treatment of depression, a pharmaceutical composition comprising D-cycloserine formulated for oral administration providing a dosage of 1000 mg/day alone or in combination with antidepressant agents and uses thereof.

Claims

1. A method of treating treatment-refractory depression, comprising:

administering D-cylcoserine at a dosage of 1000 mg/day-2000 mg/day to a patient under treatment for depression wherein said patient is receiving either an approved antidepressant agent selected from the group consisting of tetracyclic antidepressants (TeCA), selective serotine reuptake inhibitors (SSRIs), and serotonin/norepinephrin reuptake inhibitors (SNRIs), or an antipsychotic agent approved for treatment of depression, wherein said patient is treatment-refractory, and wherein said patient is experiencing side effects from receiving said antidepressant or said antipsychotic agent.

2. The method of claim 1, wherein said subject suffers from mania.

3. The method of claim 1, wherein said subject suffers from bipolar disorder.

4. The method of claim 1, wherein said anti-depressant agent is ketamine.

5. The method of claim 1, wherein said anti-depressant agent is an anti-NMDA agent.

6. The method of claim 1, wherein said subject possesses a polymorphism for a GLDC allele.

7. The method of claim 1, wherein said D-cycloserine is administered at a dosage of 1200 mg/day-2000 mg/day.

8. The method of claim 1 wherein either of said antidepressant or antipsychotic agent is administered at a dosage amount that is less than effective.

9. The method of claim 1 wherein the administration of said D-cycloserine and said antidepressant or antipsychotic agent is provided in a single pharmaceutical formulation.

10. The method of claim 1 wherein the administration of said D-cycloserine and said antidepressant or antipsychotic agent is provided as two separate pharmaceutical formulations.

11. The method of claim 1 wherein said D-cycloserine is administered separately with said antidepressant or antipsychotic agent.

12. A method of reducing the side effects of D-cycloserine in a human comprising:

administering D-cylcoserine at a dosage of 1000 mg/day-2000 mg/day together with an effective amount of either an approved antidepressant agent selected from the group consisting of tetracyclic antidepressants (TeCA), selective serotonin reuptake inhibitors (SSRIs), and serotonin/norepinephrin reuptake inhibitors (SNRIs), or an antipsychotic agent approved for treatment of depression to a patient, wherein said patient is refractory to treatment of depression.