IP Library Granted Patent US 9,592,207
Granted Patent B2
US 9,592,207 · App. 14/306,382 · Granted Mar 14, 2017

Intranasal administration of ketamine to treat depression

Inventors: Dennis S. Charney (New York, NY); Sanjay J. Mathew (New York, NY); Husseini K. Manji (Rockville, MD); Carlos A. Zarate (Rockville, MD); John H. Krystal (New Haven, CT)
Assignees: Icahn School of Medicine at Mount Sinai; Yale University; The United States of America, as represented by The Secretary, Department of Health and Human Services
A61K31/135A61K9/0019A61K9/0043A61K9/7023A61K31/137A61K45/06A61M15/08
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Quick Facts
Patent No.
US 9,592,207
App. No.
14/306,382
Granted
Mar 14, 2017
Kind
B2
Abstract

Methods and compositions for the treatment of treatment-resistant depression are described. More specifically, the invention demonstrates that intranasal administration of ketamine is effective to ameliorate the symptoms of depression in a patient who has not responded to an adequate trial of one antidepressant in the current episode and has recurrent or chronic depressive symptoms (>2 years).

Claims (15)

1. A method of treating depression comprising intranasally administering a dose of ketamine effective to alleviate depression to a patient afflicted with depression that has not responded to at least two adequate antidepressant treatments.

2. The method of claim 1 wherein said dose is between 0.13 to 0.53 mg/kg/day.

3. The method of claim 1 , which comprises administration of multiple doses of said ketamine.

4. The method of claim 1 , which comprises administration of a single dose of said ketamine over a period of 7 days.

5. The method of claim 1 , further comprising administering a pharmaceutically effective dose of a second agent, wherein said second agent is an antidepressant agent.

6. The method of claim 5 wherein said antidepressant agent is selected from the group consisting of at least one member of lithium, a pharmaceutical antidepressant, an herbal antidepressant, an anticonvulsant, a mood stabilizer, an antipsychotic agent, and a benzodiazepine.

7. The method of claim 1 wherein the depression comprises major depressive disorder.

8. The method of claim 1 wherein said effective dose is up to 250 mg/day.

9. The method of claim 1 wherein the patient has not responded to at least two adequate antidepressant trials in the current episode.

10. The method of claim 9 , which comprises administering multiple doses of said ketamine to the patient.

11. The method of claim 9 , wherein said dose is between about 0.1 mg/kg/day to about 3.0 mg/kg/day.

12. The method of claim 1 wherein the symptoms of said depression are alleviated within 2 hours of administering the ketamine.

13. The method of claim 1 wherein the symptoms of the depression are alleviated within one day of administering the ketamine.

14. The method of claim 1 wherein at least one of the adequate treatments is selected from the group consisting of selective serotonin reuptake inhibitors, selective norepinephrine reuptake inhibitors, tricyclic antidepressants, monoamine oxidase inhibitors and electroconvulsive therapy.

15. A method for treating depression in a patient that has not responded to at least two adequate antidepressant treatments comprising intranasally administering a dose of ketamine effective to alleviate depression to the patient after the adequate antidepressant treatments.

Assignments (7)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 22, 2023
From: YALE UNIVERSITY
To: THE UNITED STATES GOVERNMENT AS REPRESENTED BY THE DEPARTMENT OF VETERANS AFFAIRS; YALE UNIVERSITY
Reel/Frame 064995/0284 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 22, 2023
From: YALE UNIVERSITY
To: THE UNITED STATES GOVERNMENT AS REPRESENTED BY THE DEPARTMENT OF VETERANS AFFAIRS; YALE UNIVERSITY
Reel/Frame 064995/0384 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 23, 2017
From: ZARATE, CARLOS; MANJI, HUSSEINI
To: THE UNITED STATES OF AMERICA, AS REPRESENTED BY THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Reel/Frame 041041/0477 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 20, 2016
From: KRYSTAL, JOHN H.
To: YALE UNIVERSITY
Reel/Frame 040690/0337 →
CONFIRMATORY LICENSE Recorded Jan 6, 2015
From: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 034726/0559 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 23, 2014
From: CHARNEY, DENNIS S.; MATHEW, SANJAY J.
To: MOUNT SINAI SCHOOL OF MEDICINE
Reel/Frame 034018/0169 →
CHANGE OF NAME Recorded Oct 23, 2014
From: MOUNT SINAI SCHOOL OF MEDICINE
To: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
Reel/Frame 034036/0847 →
Continuity (4)
Continuation 14197767 · Mar 5, 2014
Continuation 11688603 · Mar 20, 2007
Provisional Application 60785108 · Mar 22, 2006
Related Publication 20150056308A1 · Feb 26, 2015