METHODS OF TREATMENT USING AN MTORC1 MODULATOR
The present invention relates to methods, compositions, and unit dosage forms useful for selectively modulating mTORC1 activity.
1 .- 22 . (canceled)
23 . A method of treating depression in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of a pharmaceutically acceptable composition comprising Compound A:
or a pharmaceutically acceptable salt thereof, wherein the therapeutically effective amount comprises a total daily dose of about 1800 mg to about 2400 mg of Compound A or a pharmaceutically acceptable salt thereof.
24 . The method according to claim 23 , wherein the total daily dose of Compound A or a pharmaceutically acceptable salt thereof is administered QD.
25 . The method according to claim 23 , wherein the treatment comprises administering a single dose of Compound A or a pharmaceutically acceptable salt thereof.
26 . The method according to claim 23 , wherein the treatment comprises administering at least two doses of Compound A or a pharmaceutically acceptable salt thereof.
27 . The method according to claim 23 , wherein the treatment comprises administering Compound A, or a pharmaceutically acceptable salt thereof, daily for at least two, three, four, five, six, or seven consecutive days.
28 . The method according to claim 26 , comprising administering a first dose of Compound A or a pharmaceutically acceptable salt thereof about 48 hours prior to administering a second dose.
29 . The method according to claim 26 , comprising administering Compound A, or a pharmaceutically acceptable salt thereof, daily, weekly, or monthly.
30 . The method according to claim 26 , comprising administering two sequential doses of 2400 mg approximately 48 hours apart.
31 . The method according to claim 23 , wherein the total daily dose of Compound A or a pharmaceutically acceptable salt thereof is administered under fasted conditions.
32 . The method according to claim 23 , wherein the total daily dose of Compound A or a pharmaceutically acceptable salt is administered under fed conditions.
33 . The method according to claim 23 , wherein the depression is treatment-resistant depression (“TRD”).
34 . The method according to claim 23 , wherein the depression is resistant to first line treatments.
35 . The method according to claim 23 , wherein the depression is resistant to second line treatments.
36 . The method according to claim 23 , wherein the patient is diagnosed with major depressive disorder (“MDD”).
37 . The method according to claim 23 , wherein the patient is experiencing a depressive episode and has had at least one inadequate response to at least one antidepressant during the depressive episode.
38 . The method according to claim 23 , wherein the patient is experiencing a depressive episode and has had at least one inadequate response to at least two, three, or four different antidepressants during the depressive episode.
39 . The method according to claim 23 , wherein the patient is assessed to have a Montgomery-Asberg Depression Rating Scale (MADRS) total score of ≥21 prior to treatment.
40 . The method according to claim 23 , wherein the patient is assessed to have a Raskin Depression Rating Scale score of ≥9 prior to treatment.
41 . The method according to claim 23 , wherein administration is oral.
42 . The method according to claim 23 , wherein the total daily dose is a single unit dosage form.
43 . The method according to claim 23 , wherein the total daily dose comprises a liquid unit dosage form comprising about 2400 mg of compound A, or pharmaceutically acceptable salt thereof.