Novel methods

Abstract

The disclosure provides methods for the treatment of Bipolar II Disorder, comprising administering to a patient in need thereof, a therapeutically effective amount of lumateperone, in free or pharmaceutically acceptable salt form, optionally in deuterated form.

We claim: 
     
         1 . A method for the treatment of Bipolar II Disorder, comprising administering to a patient in need thereof, a therapeutically effective amount of lumateperone, in free or pharmaceutically acceptable salt form, optionally in deuterated form. 
     
     
         2 . The method of  claim 1 , wherein the lumateperone is in the form of a toluenesulfonic acid addition salt (e.g., a mono-tosylate salt or bis-tosylate salt). 
     
     
         3 . The method of  claim 2 , wherein the salt is a solid crystalline salt. 
     
     
         4 . The method of  claim 1 , wherein the lumateperone is in deuterated form. 
     
     
         5 . The method of  claim 1 , wherein the lumateperone, in free or pharmaceutically acceptable salt form, optionally in deuterated form, is administered in a total daily dose equivalent to 6 to 60 mg of free base. 
     
     
         6 . The method of  claim 1 , wherein the method comprises once daily administration of a tablet or capsule comprising about 60 mg of lumateperone tosylate in combination or association with a pharmaceutically acceptable diluent or carrier. 
     
     
         7 . The method of  claim 1 , wherein the condition to be treated is depression in Bipolar II Disorder, or a depressive episode associated with Bipolar II Disorder (e.g., a major depressive episode). 
     
     
         8 . The method of  claim 1 , wherein during the course of treatment the patient shows improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score and/or shows improvement in Clinical Global Impression Scale for Bipolar for Severity of Illness (CGI-BP-S) (e.g., improvement within 8 days or less after initiation of treatment). 
     
     
         9 . The method of  claim 1 , wherein the treatment does not result in one or more of hyperglycemia, dyslipidemia, weight gain, suicidal ideation or suicidal thoughts, or extrapyramidal symptoms including akathisia. 
     
     
         10 . The method of  claim 1 , wherein the patient is concurrently receiving a mood-stabilizing agent. 
     
     
         11 . The method of  claim 1 , wherein the patient was previously treated with an SSRI (e.g., such treatment was ineffective and/or discontinued, such as due to side effects). 
     
     
         12 . The method of  claim 1 , wherein the patient was previously treated with an antipsychotic, such as an atypical antipsychotic (e.g., such treatment was ineffective and/or discontinued, such as due to side effects). 
     
     
         13 . The method of  claim 12 , wherein said antipsychotic is selected from haloperidol, aripiprazole, quetiapine, olanzapine, risperidone, lurasidone, paliperidone, iloperidone, ziprasidone, brexipiprazole, asenapine, clozapine, and zotepine.