IP Library Granted Patent US 8,785,500
Granted Patent B2
US 8,785,500 · App. 11/688,603 · Granted Jul 22, 2014

Intranasal administration of ketamine to treat depression

Inventors: Dennis S. Charney (Chappaqua, NY); Sanjay J. Mathew (New York, NY); Husseini K. Manji (Rockville, MD); Carlos A. Zarate, Jr. (Germantown, MD); John H. Krystal (Woodbridge, CT)
Assignees: Icahn School of Medicine at Mount Sinai; Yale University; National Institute of Health
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Quick Facts
Patent No.
US 8,785,500
App. No.
11/688,603
Granted
Jul 22, 2014
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 (18)

1. A method of treating depression, comprising intranasally administering to a patient who suffers from said depression and who has not responded to at least two adequate antidepressant treatments a composition comprising ketamine at a dosage sufficient to alleviate symptoms of said depression, wherein the adequate antidepressant treatments are selected from the group consisting of atypical antipsychotics, benzodiazepines, bupropion, electroconvulsive therapy, lamotrigine, lithium, monoamine oxidase inhibitors, selective norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors, tricyclic antidepressants, valproic acid, nefazodone, trazodone, and pramipexole.

2. The method of claim 1 , wherein said ketamine is in a pharmaceutically acceptable carrier and is administered at a dose of between about 0.1 mg/kg per day to about 3.0 mg/kg/day.

3. The method of claim 1 , wherein the symptoms of said depression are alleviated within 2 hours of intranasal administration of said ketamine.

4. The method of claim 1 , wherein said method comprises intranasal administration of a single dose of said ketamine.

5. The method of claim 1 , wherein said method comprises intranasal administration of multiple doses of said ketamine.

6. The method of claim 1 , wherein a single intranasal administration of said ketamine is sufficient to alleviate said symptoms for 7 days.

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

8. The method of claim 7 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.

9. The method of claim 1 , wherein said two adequate antidepressant treatments comprise two adequate antidepressant treatments with medicines from two different classes of antidepressant medicines.

10. The method of claim 1 , wherein the symptoms of the depression are alleviated within one day of administering the composition.

11. The method of claim 1 , wherein at least one of the adequate treatments is selective serotonin reuptake inhibitor.

12. The method of claim 1 , wherein at least one of the adequate treatments is a selective norepinephrine reuptake inhibitor.

13. The method of claim 1 , wherein at least one of the adequate treatments is a tricyclic antidepressant.

14. The method of claim 1 , wherein at least one of the adequate treatments is a monamine oxidase inhibitor.

15. The method of claim 1 , wherein at least one of the adequate treatments is electroconvulsive therapy.

16. The method of claim 1 , wherein at least one of the adequate treatments is a benzodiazepine.

17. The method of claim 1 , wherein at least one of the adequate treatments is bupropion.

18. The method of claim 1 , wherein the adequate treatments are selected from the group consisting of selective serotonin reuptake inhibitors, selective norepinephrine reuptake inhibitors, tricyclic antidepressants, monoamine oxidase inhibitors, and electroconvulsive therapy.

Assignments (8)
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 →
CONFIRMATORY LICENSE Recorded Jul 7, 2016
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 039276/0348 →
CHANGE OF NAME Recorded Mar 22, 2014
From: MOUNT SINAI SCHOOL OF MEDICINE
To: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
Reel/Frame 032503/0420 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 18, 2010
From: MANJI, HUSSEINI; ZARATE, CARLOS, JR.
To: THE UNITED STATES OF AMERICA, AS REPRESENTED BY THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Reel/Frame 024403/0360 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 14, 2008
From: MANJI, HUSSEINI; ZARATE, JR., CARLOS
To: THE UNITED STATES OF AMERICA, AS REPRESENTED BY THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Reel/Frame 021233/0474 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 30, 2008
From: CHARNEY, DENNIS S.; MATHEW, SANJAY J.
To: MOUNT SINAI SCHOOL OF MEDICINE
Reel/Frame 021173/0706 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 30, 2008
From: KRYSTAL, JOHN H.
To: YALE UNIVERSITY
Reel/Frame 021173/0745 →
Continuity (2)
Provisional Application 60785108 · Mar 22, 2006
Related Publication 20070287753A1 · Dec 13, 2007