# US 10,869,844 B2 · Methods for the treatment of depression

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- Number: US 10,869,844 B2
- Document ID: US10869844B2
- Status: Granted
- Kind: B2
- Application number: 16/727,594
- Filed: 2019-12-26
- Published: 2020-08-06
- Granted: 2020-12-22
- Earliest claimed: 2014-09-15
- Assignees: Janssen Pharmaceutica NV
- Applicants: Janssen Pharmaceutica NV
- Inventors: Lodewijk Ivo Caers; Jaskaran Singh; Peter Nicholas Zannikos; Wayne C. Drevets; Ella Daly; Carla Marie Canuso; Margaret Fedgchin; Frank Wiegand
- Web page: https://patentgrep.com/patent/US10869844B2

## CPC

- A61K 31/135: having aromatic rings {, e.g. ketamine, nortriptyline (methadone A61K31/137)}
- A61K 9/0043: {Nose}
- A61P 25/24: Antidepressants
- C12Q 1/6883: for diseases caused by alterations of genetic material
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/156: Polymorphic or mutational markers
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

The present invention is directed to methods and dosing regimens for the treatment of depression (preferably, treatment resistant depression), for the treatment of depression in a suicidal patient, and/or for the treatment and/or prevention of suicidality (e.g. suicidal ideations).

## Claims

### Claim 1

A method of treating major depressive disorder in a human patient in need thereof, comprising:
intranasally administering (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone in an induction dosage to the patient in an amount in the range of from about 56 mg to about 84 mg in an induction phase, wherein the induction phase comprises a treatment period of about four weeks, and the induction dosage is administered at a frequency of twice per week during the induction phase.

### Claim 2 (depends on 1)

The method of claim 1, wherein the induction dosage is about 56 mg or about 84 mg.

### Claim 3 (depends on 2)

The method of claim 2, wherein the patient exhibits suicidal ideation or behavior.

### Claim 4 (depends on 2)

The method of claim 2, wherein the major depressive disorder is treatment resistant depression.

### Claim 5 (depends on 2)

The method of claim 2, further comprising adjunctive treatment with a therapeutically effective amount of one or more antidepressants during the induction phase.

### Claim 6 (depends on 5)

The method of claim 5, wherein the patient exhibits suicidal ideation or behavior.

### Claim 7 (depends on 6)

The method of claim 6, wherein the (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone is administered as its corresponding hydrochloride salt during the induction phase.

### Claim 8 (depends on 7)

The method of claim 7, wherein the one or more antidepressants is an oral antidepressant.

### Claim 9 (depends on 5)

The method of claim 5, wherein the major depressive disorder is treatment resistant depression.

### Claim 10 (depends on 9)

The method of claim 9, wherein the (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone is administered as its corresponding hydrochloride salt during the induction phase.

### Claim 11 (depends on 2)

The method of claim 2, wherein the induction dosage is about 84 mg.

### Claim 12 (depends on 11)

The method of claim 11, wherein the depression major depressive disorder is treatment resistant depression.

### Claim 13 (depends on 11)

The method of claim 11, wherein the patient exhibits suicidal ideation or behavior.

### Claim 14 (depends on 11)

The method of claim 11, further comprising adjunctive treatment with a therapeutically effective amount of one or more antidepressants during the induction phase.

### Claim 15 (depends on 14)

The method of claim 14, wherein the patient exhibits suicidal ideation or behavior.

### Claim 16 (depends on 15)

The method of claim 15, wherein the (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone is administered as its corresponding hydrochloride salt during the induction phase.

### Claim 17 (depends on 14)

The method of claim 14, wherein the major depressive disorder is treatment resistant depression.

### Claim 18 (depends on 17)

The method of claim 17, wherein the (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone is administered as its corresponding hydrochloride salt during the induction phase.

### Claim 19 (depends on 1)

The method of claim 1, wherein the (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone is administered as its corresponding hydrochloride salt during the induction phase.

### Claim 20

A method of treating depression in a human patient in need thereof, the method having an induction phase and a subsequent maintenance phase, comprising:
intranasally administering (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone in an induction dosage to the patient in an amount in the range of from about 28 mg to about 84 mg in the induction phase, wherein the induction phase comprises a treatment period of about four weeks, and the induction dosage is administered at a frequency of twice per week during the induction phase; and
intranasally administering (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone in a maintenance dosage in an amount in the range of from about 56 mg to about 84 mg in the maintenance phase, wherein the maintenance dosage is administered at a frequency of once per week or once every two weeks.

### Claim 21 (depends on 20)

The method of claim 20, wherein the induction dosage is about 56 mg or about 84 mg, and the maintenance dosage is about 56 mg or about 84 mg.

### Claim 22 (depends on 21)

The method of claim 21, wherein the depression is major depressive disorder.

### Claim 23 (depends on 21)

The method of claim 21, wherein the depression is treatment resistant depression.

### Claim 24 (depends on 21)

The method of claim 21, further comprising adjunctive treatment with a therapeutically effective amount of one or more antidepressants during the induction phase and the maintenance phase.

### Claim 25 (depends on 24)

The method of claim 24, wherein the depression is major depressive disorder.

### Claim 26 (depends on 25)

The method of claim 25, wherein the (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone is administered as its corresponding hydrochloride salt during the induction phase and maintenance phase.

### Claim 27 (depends on 24)

The method of claim 24, wherein the depression is treatment resistant depression.

### Claim 28 (depends on 27)

The method of claim 27, wherein the (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone is administered as its corresponding hydrochloride salt during the induction phase and maintenance phase.

### Claim 29 (depends on 28)

The method of claim 28, wherein the one or more antidepressants is an oral antidepressant.

### Claim 30 (depends on 20)

The method of claim 20, wherein the (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone is administered as its corresponding hydrochloride salt during the induction phase and maintenance phase.