Methods of monitoring adherence to lurasidone therapy

Abstract

The present disclosure provides methods for monitoring subject (e.g., patient) adherence to lurasidone therapy, for example as a component of treating a subject for a mental health disorder such as schizophrenia.

I/We claim: 
     
         1 . A method for identifying a subject as non-compliant with a prescribed lurasidone therapy, the method comprising:
 obtaining a fluid sample from a subject who has been prescribed lurasidone therapy;   determining a level of M8/M9, M21, and/or M22 in the fluid sample; and   identifying the subject as adherent to the prescribed lurasidone therapy if the fluid sample contains M8/M9, M21, and/or M22 above a threshold level but non-adherent if the fluid sample contains no M8/M9, M21, and/or M22 or an amount of M8/M9, M21, and/or M22 below a threshold level.   
     
     
         2 . The method of  claim 1  further comprising counseling the subject on dangers of non-adherence to lurasidone therapy if the subject is identified as non-adherent. 
     
     
         3 . The method of  claim 1 , wherein the threshold level is a minimum detectable amount of M8/M9, M21, and/or M22. 
     
     
         4 . The method of  claim 1 , wherein the threshold level is about 50 ng/mL. 
     
     
         5 . The method of  claim 1 , wherein the threshold level is about 5 ng/mL. 
     
     
         6 . The method of  claim 1 , wherein the fluid sample is a urine sample. 
     
     
         7 . A method of determining compliance with lurasidone therapy in a subject, the method comprising:
 obtaining a fluid sample from the subject;   analyzing the fluid sample for presence or absence of an analyte; and   identifying the subject as compliant if the analyte is present in the fluid sample.   
     
     
         8 . The method of  claim 7 , wherein the analyte comprises lurasidone and/or a lurasidone metabolite. 
     
     
         9 . The method of  claim 7 , wherein the analyte is selected from the group consisting of M5, M10, M11, M11 Gluc, ID-20221, ID-20222, M8/M9, M21, and M22. 
     
     
         10 . The method of  claim 8 , wherein the analyte comprises M8/M9, M21, and/or M22. 
     
     
         11 . The method of  claim 7 , wherein the analyte is considered present in the fluid sample if the analyte is detected above a threshold value. 
     
     
         12 . The method of  claim 11 , wherein the threshold value is about 50 ng/mL. 
     
     
         13 . The method of  claim 11 , wherein the threshold value is about 5 ng/mL.