Method of treating major depressive disorder
The present invention provides a method for safe and efficacious administration of esketamine.
1. A method of treating major depressive disorder (MDD) in a
human patient in need thereof consisting essentially of orally administering to said patient an oral dosage form of between 20 mg and 40 mg of esketamine over a treatment regimen of at least 28 days;
and optionally administering to said patient a second medication that is an antidepressant, an antimanic agent, or an anxiolytic drug that does not alter the metabolism of the esketamine in the patient,
wherein the ratio of S-norketamine C max to esketamine C max after the co-administration of the esketamine and the second medication is at least 6.
2. The method of claim 1 , wherein the patient is administered an oral dosage form of 20 mg of esketamine.
3. The method of claim 1 , wherein the patient is administered an oral dosage form of 30 mg of esketamine.
4. The method of claim 1 , wherein the patient is administered an oral dosage form of 40 mg of esketamine.
5. The method of claim 1 , wherein the treatment regimen is between 28 days and 730 days.
6. The method of claim 5 , wherein the treatment regimen is for at least a year.
7. The method of claim 1 , wherein the administration is at least once daily over the treatment regimen.
8. The method of claim 7 , wherein the administration is once daily over the treatment regimen.
9. The method of claim 1 , wherein the administration is intermittent over the treatment regimen.
10. The method of claim 9 , wherein the frequency of the administration varies over the treatment regimen.
11. The method of claim 1 , wherein the esketamine is esketamine hydrochloride.
12. The method of claim 1 , wherein the treatment comprises a reduction in the human patient's symptoms of MDD.
13. The method of claim 12 , wherein the reduction in the human patient's symptoms of MDD is measured, as compared to baseline, at at least day 28 as compared to baseline is measured by a reduction on the Montgomery −Åsberg Depression Rating Scale.
14. The method of claim 12 , wherein the reduction in the human patient's symptoms of MDD is measured, as compared to baseline, at at least day 28, on a Clinical Global Impression Improvement score.
15. The method of claim 12 , wherein the reduction in the human patient's symptoms of MDD is measured, as compared to baseline, at at least day 28, on a Global Impression Severity score.
16. The method of claim 12 , wherein the human patient's symptoms of MDD are reduced at at least day 28 as compared to placebo.
17. A method of treating major depressive disorder (MDD) in a human patient in need thereof consisting essentially of
orally administering to said patient an oral dosage form of between 20 mg and 40 mg of esketamine over a treatment regimen of at least 28 days;
and optionally administering to said patient a second medication that is an antidepressant, an antimanic agent, or an anxiolytic drug that does not alter the metabolism of the esketamine in the patient, wherein the ratio of S-norketamine C max to esketamine C max after the coadministration of the esketamine and the second medication is at least 6;
wherein the administration results in a reduction in the human patient's symptoms of MDD, when measured at at least day 28 as compared to placebo.