Claims for Patent: 11,311,500

Summary for Patent: 11,311,500

Title:	Methods for the treatment of depression
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).
Inventor(s):	Caers; Lodewijk Ivo (Beerse, BE), Singh; Jaskaran (San Diego, CA), Zannikos; Peter Nicholas (Doylestown, PA), Drevets; Wayne C. (Rancho Santa Fe, CA), Daly; Ella (Doylestown, PA), Canuso; Carla Marie (Yardley, PA), Fedgchin; Margaret (Collegeville, PA), Wiegand; Frank (Annandale, NJ)
Assignee:	Janssen Pharmaceutica NV (Beerse, BE)
Application Number:	17/345,395
Patent Claims:	1. A method of treating major depressive disorder in a human patient in need thereof, comprising: intranasally administering an aqueous formulation comprising (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone and/or a pharmaceutically acceptable salt thereof in an induction dosage to the patient to provide a therapeutically effective amount of about 56 mg or about 84 mg of (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone 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. 2. The method of claim 1, further comprising adjunctive treatment with a therapeutically effective amount of one or more antidepressants during the induction phase. 3. The method of claim 2, wherein the one or more antidepressants is an oral antidepressant. 4. The method of claim 3, wherein the major depressive disorder is major depressive disorder with suicidal ideation or behavior. 5. The method of claim 4, wherein the aqueous formulation comprises (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride during the induction phase. 6. The method of claim 3, wherein the major depressive disorder is treatment resistant depression. 7. The method of claim 6, wherein the aqueous formulation comprises (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride during the induction phase. 8. The method of claim 1, wherein the major depressive disorder is major depressive disorder with suicidal ideation or behavior. 9. The method of claim 8, wherein the aqueous formulation comprises (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride during the induction phase. 10. The method of claim 1, wherein the major depressive disorder is treatment resistant depression. 11. The method of claim 10, wherein the aqueous formulation comprises (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride during the induction phase. 12. A method of treating major depressive disorder in a human patient in need thereof, the method having an induction phase and a subsequent maintenance phase, comprising: intranasally administering an aqueous formulation comprising (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone and/or a pharmaceutically acceptable salt thereof in an induction dosage to the patient to provide a therapeutically effective amount of about 56 mg or about 84 mg of (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone 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 an aqueous formulation comprising (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone and/or a pharmaceutically acceptable salt thereof in a maintenance dosage to the patient to provide a therapeutically effective amount of about 56 mg or about 84 mg of (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone in the maintenance phase, wherein the maintenance dosage is administered at a frequency of once per week or once every two weeks. 13. The method of claim 12, further comprising adjunctive treatment with a therapeutically effective amount of one or more antidepressants during the induction phase and the maintenance phase. 14. The method of claim 13 wherein the one or more antidepressants is an oral antidepressant. 15. The method of claim 14, wherein the major depressive disorder is major depressive disorder with suicidal ideation or behavior. 16. The method of claim 15, wherein the aqueous formulation comprises (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride during the induction phase and maintenance phase. 17. The method of claim 14, wherein the major depressive disorder is treatment resistant depression. 18. The method of claim 17, wherein the aqueous formulation comprises (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride during the induction phase and maintenance phase. 19. The method of claim 12, wherein the major depressive disorder is major depressive disorder with suicidal ideation or behavior. 20. The method of claim 19, wherein the aqueous formulation comprises (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride during the induction phase and maintenance phase. 21. The method of claim 12, wherein the major depressive disorder is treatment resistant depression. 22. The method of claim 21, wherein the aqueous formulation comprises (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride during the induction phase and maintenance phase.