Methods and kits for treating depression

Patent metadata

Field	Value
Publication number	US-2016338977-A1
Application number	US-201615159257-A
Country	US
Kind code	A1
Filing date	May 19, 2016
Priority date	May 20, 2015
Publication date	Nov 24, 2016
Grant date	—

Abstract

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

First claim

We claim:

1 . A method of treating depression in a patient, said method comprising:
(a) administering an effective amount of esketamine to said patient at a given frequency and during an induction phase of defined duration; and (b) administering an effective amount of esketamine to said patient less frequently during a subsequent maintenance phase of defined duration.

2 . The method of claim 1 , wherein said esketamine is administered during said induction phase at a frequency of at least once weekly for at least about 1 week; and said esketamine is administered during said maintenance phase at a frequency of no more often than every other day.

3 . The method of claim 1 or 2 , wherein said induction phase is about 1 to about 12 weeks.

4 . The method of claim 1 or 2 , wherein said induction phase is about 2 to about 8 weeks.

5 . The method of claim 1 or 2 , wherein said induction phase is at least about 2 weeks.

6 . The method of claim 1 or 2 , wherein said induction phase is at least about 3 weeks.

7 . The method of claim 1 or 2 , wherein said induction phase is at least about 4 weeks.

8 . The method of claim 1 or 2 , wherein said maintenance phase further comprises adjusting the frequency of administration of said esketamine.

9 . The method of claim 1 or 2 , wherein said frequency of administration of said esketamine is increased in said maintenance phase.

10 . The method of claim 1 or 2 , wherein said frequency of administration of said esketamine is decreased in said maintenance phase.

11 . The method of any one of claims 1 to 10 , wherein said effective amount in each dose is about 10 to about 200 mg.

12 . The method of claim 11 , wherein said effective amount in each dose is about 14 mg.

13 . The method of claim 11 , wherein said effective amount in each dose is about 28 mg.

14 . The method of claim 11 , wherein said effective amount in each dose is about 56 mg.

15 . The method of claim 11 , wherein said effective amount in each dose is about 84 mg.

16 . The method of claim 1 or 2 , wherein said esketamine is administered during said induction phase, said maintenance phase, or any combination thereof at the lowest dosing frequency at which an esketamine response is observed in said patient.

17 . The method of claim 1 or 2 , wherein said esketamine is administered at the lowest dosage amount at which an esketamine response is observed in said patient.

18 . The method of claim 1 or 2 , wherein said esketamine is administered non-orally during said induction phase.

19 . The method of claim 18 , wherein said esketamine is administered intravenously, intranasally, intramuscularly, subcutaneously, transdermally, buccally, or rectally during said induction phase.

20 . The method of claim 19 , wherein said esketamine is administered intranasally during said induction phase.

21 . The method of claim 1 or 2 , wherein said esketamine is administered orally during said maintenance phase.

22 . The method of claim 1 or 2 , wherein said esketamine is administered orally during said induction phase.

23 . The method of claim 1 or 2 , wherein a placebo is administered on any day during said induction phase or maintenance phase on which said esketamine is not administered.

24 . The method of any one of claims 1 to 23 , wherein said depression is treatment resistant depression.

25 . The method of any one of claims 1 to 24 , wherein the dosage of esketamine is optimized for a patient having or being predisposed to depression.

26 . The method of any one of claims 1 to 25 , wherein the effect of said esketamine is analyzed by evaluating the depression of said subject.

27 . A kit for administering esketamine to a patient in need thereof, said kit comprising:
(a) a first dosage unit comprising an effective amount of esketamine for administration to a patient at a given frequency in an induction phase of at least about 1 week; and (b) a second dosage unit comprising an effective amount of esketamine for administration to said patient less frequently than in said induction phase of a defined duration in a maintenance phase; wherein said second dosage unit is administered to said patient after said induction phase.

28 . A kit for administering esketamine to a patient in need thereof, said kit comprising:
(a) a first dosage unit comprising an effective amount of esketamine for administration to a patient at a frequency of at least once weekly in an induction phase of at least about 1 week; and (b) a second dosage unit comprising an effective amount of esketamine for administration to said patient at a frequently less than the frequency in said induction phase in a maintenance phase; wherein said second dosage unit is administered to said patient after said induction phase.

29 . The kit of claim 27 or 28 , wherein said first dosage unit is a non-oral dosage unit.

30 . The kit of claim 29 , wherein said non-oral dosage unit is an intravenous, intranasal, intramuscular, subcutaneous, transdermal, buccal, or rectal dosage unit.

31 . The kit of claim 30 , wherein said first dosage unit is an intranasal dosage unit.

32 . The kit of claim 27 or 28 , wherein said first dosage unit is an oral dosage unit.

33 . The kit of claim 27 or 28 , wherein said second dosage unit is an oral dosage unit.

34 . The kit of claim 27 or 28 , further comprising a means for evaluating said patient's depression.

35 . The kit of claim 34 , further comprising a depression scale rating scale questionnaire.

Assignees

• Janssen Pharmaceutica Nv

Inventors

• Singh Jaskaran
• Caers Ivo
• Daly Ella
• Drevets Wayne

Classifications

• A61K31/135 Primary

  having aromatic rings {, e.g. ketamine, nortriptyline (methadone A61K31/137)} · CPC title

• A61K9/0019

  Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00) · CPC title

• A61K9/007

  Pulmonary tract; Aromatherapy · CPC title

• A61P25/24

  Antidepressants · CPC title

• A61K31/137 Primary

  Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone} · CPC title