Treatment of schizophrenia

Abstract

The present invention relates to a method of treating schizophrenia in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a selective D3 antagonist, wherein said subject has at least one negative symptom (NS) among the following core negative symptoms in PANSS: Blunted Affect (N1), Emotional Withdrawal (N2), Poor Rapport (N3), Passive withdrawal (N4), and Lack of Spontaneity (N6); with moderate or higher severity. Methods for improving the probability of success and/or the effect of a treatment of schizophrenia in a subject in need thereof are also described.

1 - 10 . (canceled) 
     
     
         11 . A method of improving the probability of success and/or the effect of a treatment of schizophrenia in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a selective D3 antagonist,
 wherein said subject has at least one negative symptom (NS) among the following core negative symptoms in PANSS:
 Blunted Affect (N1), 
 Emotional Withdrawal (N2), 
 Poor Rapport (N3), 
 Passive withdrawal (N4), and 
 Lack of Spontaneity (N6), 
   
       with moderate or higher severity,
 wherein said moderate or higher severity corresponds to a score equal to 4 or higher before beginning of said treatment. 
 
     
     
         12 . The method of  claim 11 , wherein said selective D3 antagonist is N-(3-{4-[4-(8-oxo-8H-[1,3]dioxolo[4,5-g]chromen-7-yl)-butyl]-piperazin-1-yl}-phenyl)-methanesulfonamide of the following formula 1 or a pharmaceutically acceptable salt thereof: 
       
         
           
           
               
               
           
         
       
     
     
         13 . The method of  claim 12 , wherein said pharmaceutically acceptable salt is N-(3-{4-[4-(8-oxo-8H-[1,3]dioxolo[4,5-g]chromen-7-yl)-butyl]-piperazin-1-yl}-phenyl)-methanesulfonamide hydrochloride. 
     
     
         14 . The method of  claim 11 , wherein said subject suffers from acute exacerbation of schizophrenia before beginning of said treatment. 
     
     
         15 . The method of  claim 14 , wherein said acute exacerbation is characterized by a PANSS total score ≥70 and <120. 
     
     
         16 . The method of  claim 15 , wherein said subject meets the following additional criteria:
 a. a well-documented diagnosis of schizophrenia for a minimum of 1 year; and   b. a Clinical Global Impression of Severity (CGI-S) score ≥4,   
       before beginning of said treatment. 
     
     
         17 . The method of  claim 11 , wherein said therapeutically effective amount is a dose of 1 to 100 mg once daily or 0.5 to 50 mg twice daily. 
     
     
         18 . The method of  claim 17 , wherein said therapeutically effective amount is a fixed dose of 40 mg once daily or 20 mg twice daily. 
     
     
         19 . The method of  claim 17 , wherein said dose is administered orally. 
     
     
         20 . The method of  claim 17 , wherein said dose is administered for 6 weeks or more to the subject in need thereof.