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Last Updated: March 14, 2025

Claims for Patent: 11,026,951

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Summary for Patent: 11,026,951

Title:	Methods of treating bipolar disorder
Abstract:	The disclosure provides the use of particular substituted heterocycle fused gamma-carboline compounds as pharmaceuticals for the treatment of residual symptoms of psychosis or schizophrenia. The disclosure also provides novel long acting injectable formulations of particular substituted heterocycle fused gamma-carboline compounds and use of such long acting injectable formulations for the treatment of residual symptoms of psychosis or schizophrenia.
Inventor(s):	Vanover; Kimberly (New York, NY), Li; Peng (New Milford, NJ), Mates; Sharon (New York, NY), Davis; Robert (San Diego, CA), Wennogle; Lawrence P. (Hillsborough, NJ)
Assignee:	INTRA-CELLULAR THERAPIES, INC. (New York, NY)
Application Number:	16/507,956
Patent Claims:	1. A method for the treatment of bipolar disorder I and/or bipolar II disorder comprising administering to a patient in need thereof an effective amount of a Compound of Formula I: ##STR00015## wherein: X is --N(CH.sub.3)-- and Y is --C(O)--; in free or pharmaceutically acceptable salt form, wherein said Compound is not used in combination with another antipsychotic agent. 2. The method according to claim 1, wherein the compound of Formula I is in pharmaceutically acceptable salt form. 3. The method according to claim 1, wherein the compound of Formula I is in toluenesulfonic acid addition salt form. 4. The method according to claim 1, wherein the bipolar disorder is bipolar I disorder. 5. The method according to claim 1, wherein the bipolar disorder is bipolar II disorder. 6. The method according to claim 1, wherein the effective amount of the Compound of Formula I is 20 mg to 60 mg per day, measured as the weight of the corresponding free base form of the Compound. 7. The method according to claim 1, wherein the effective amount of the Compound of Formula I is 40 mg to 60 mg per day, measured as the weight of the corresponding free base form of the Compound. 8. The method according to claim 1, wherein the effective amount of the Compound of Formula I is about 40 mg per day, measured as the weight of the corresponding free base form of the Compound. 9. The method according to claim 1, wherein the compound is in toluenesulfonic acid addition salt form and the effective amount of the Compound of Formula I is 60 mg of the salt form administered once per day (equivalent to about 41.7 mg of the free base). 10. The method according to claim 1, wherein the patient has bipolar disorder with psychotic symptoms. 11. The method according to claim 1, wherein the patient has bipolar depression. 12. The method according to claim 1, wherein the method is effective in treating the symptoms of depression of bipolar disorder. 13. The method according to claim 4, wherein the method is effective in treating the symptoms of depression of bipolar disorder. 14. The method according to claim 5, wherein the method is effective in treating the symptoms of depression of bipolar disorder. 15. The method according to claim 9, wherein the bipolar disorder is bipolar I disorder. 16. The method according to claim 15, wherein the method is effective in treating the symptoms of depression of bipolar disorder. 17. The method according to claim 9, wherein the bipolar disorder is bipolar II disorder. 18. The method according to claim 17, wherein the method is effective in treating the symptoms of depression of bipolar disorder. 19. The method according to claim 1, wherein the Compound is administered as the sole therapeutic agent for the treatment of said bipolar disorder. 20. The method according to claim 1, wherein the method does not result in hyperprolactinemia, EPS/akathisia, weight gain or cardiovascular side effects. 21. The method according to claim 9, wherein the Compound is administered as the sole therapeutic agent for the treatment of said bipolar disorder. 22. The method according to claim 9, wherein the method does not result in hyperprolactinemia, EPS/akathisia, weight gain or cardiovascular side effects. 23. The method according to claim 1, wherein the method does not result in EPS/akathisia or weight gain. 24. The method according to claim 9, wherein the method does not result in EPS/akathisia or weight gain.

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