METHODS FOR TREATING DEPRESSIVE STATES
The present disclosure relates to method of treating or preventing depression in a human subject having Major Depressive Disorder or a Major Depressive Episode, the method comprising (a) an induction phase, comprising administering to the subject a therapeutic amount of dexmedetomidine or a pharmaceutically acceptable salt thereof in combination with a therapeutic amount of a selective serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitors (SNRI) from about 1 day to about 28 days, followed by (b) a maintenance phase comprising administering to the subject a therapeutic amount of the SSRI/SNRI.
1 . A method of treating major depressive disorder or a major depressive episode in a human subject in need thereof, comprising:
(i) administering at least one daily dose of dexmedetomidine or a pharmaceutically acceptable salt thereof to the subject for a period of at least 14 days, and
(ii) administering an anti-depressant to the subject.
2 . The method of claim 1 , wherein dexrnedetomidine or a pharmaceutically acceptable salt thereof is administered twice daily to the subject.
3 . The method of claim 2 , wherein the first dose of dexmedetomidine or a pharmaceutically acceptable salt thereof is administered in the morning and second dose is administered in the evening.
4 . The method of claim 2 , wherein the first dose of dexmedetomidine or a pharmaceutically acceptable salt thereof is lower than the second dose of dexmedetomidine or a pharmaceutically acceptable salt thereof.
5 . The method of claim 1 , wherein the total daily dexmedetomidine or a pharmaceutically acceptable salt thereof dose is about 30 micrograms to about 200 micrograms.
6 . The method of claim 5 , wherein the first dose of dexmedetomidine is about 30 micrograms and the second dose of dexmedetomidine or a pharmaceutically acceptable salt thereof is about 60 micrograms.
7 . The method of claim 5 , wherein the first dose of dexmedetomidine is about 40 micrograms and the second dose of dexmedetomidine or a pharmaceutically acceptable salt thereof is about 80 micrograms.
8 . The method of claim 7 , wherein dexmedetomidine or a pharmaceutically acceptable salt thereof is administered through routes selected from oral, parenteral, topical, intranasal, inhalation or oromucosal.
9 . The method of claim 8 , wherein dexmedetomidine or a pharmaceutically acceptable salt thereof is administered oromucosally in the form of tablet, wafer, patch, liquid spray, gel, film or spray.
10 . The method of claim 9 , wherein dexmedetomidine or a pharmaceutically acceptable salt thereof is administered oromucosally in the form of a film.
11 . The method of claim 1 , wherein the subject is non-agitated at the time of administration.
12 . The method of claim 1 , wherein the major depressive disorder is associated with anxious distress.
13 . The method of claim 1 , wherein the antidepressant is administered orally for an extended period of time for at least 1 month, at least 2 months, at least 3 months, at least 4 months, at least 5 months or more till the underlying disease resolves.
14 . The method of claim 1 , wherein the anti-depressant is an SSRI or an SNRI.
15 - 18 . (canceled)
19 . The method of claim 14 , wherein the SSRI is escitalopram or citalopram or a pharmaceutically acceptable salt thereof.
20 . The method of claim 14 , wherein the SNRI is selected from the group consisting of desvenlafaxine, venlafaxine, levomilnacipran, milnacipran, duloxetine, atomoxetine, sibutramine, reboxetine, tramadol or a pharmaceutically acceptable salt or ester or enantiomer thereof.
21 - 78 . (canceled)