Methods of monitoring for adherence to aripiprazole therapy

Abstract

Methods for helping to monitor subject adherence with a prescribed antipsychotic drug treatment regimen are disclosed.

What is claimed is: 
     
         1 . A method of treating schizophrenia in a subject in need thereof, the method comprising:
 identifying a subject who has been diagnosed with schizophrenia and who has been prescribed aripiprazole therapy;   receiving a urine sample from the subject;   determining a concentration of at least one aripiprazole metabolite in the urine;   determining a concentration of at least one aripiprazole analyte in the urine; and   recommending a modification to the prescribed aripiprazole therapy if the concentration of the at least one aripiprazole analyte falls outside a normal distribution of the aripiprazole analyte,   wherein the normal distribution of the aripiprazole analyte comprises normalized concentrations of the aripiprazole analyte associated with subjects known to be adherent to the aripiprazole therapy.   
     
     
         2 . The method of  claim 1 , wherein the at least one aripiprazole analyte is one or more of: aripiprazole, a dehydrogenated aripiprazole metabolite, a hydroxylated aripiprazole metabolite, an N-dealkylated aripiprazole metabolite, a glucuronidated aripiprazole metabolite, and a sulfated aripiprazole metabolite. 
     
     
         3 . The method of  claim 2 , wherein the dehydrogenated aripiprazole metabolite is selected from the group consisting of: dehydroaripiprazole, OPC-14857, OPC-3952, DM-1459 and DM-1460. 
     
     
         4 . The method of  claim 2 , wherein the hydroxylated aripiprazole derivative is selected from the group consisting of DM-1451, DM-1452, DM-1454, DM-1458, DM-1459, DM-1460, OPC-14857 and DM-1431. 
     
     
         5 . The method of  claim 2 , wherein the N-dealkylated aripiprazole derivative is selected from the group consisting of OPC3373, DCPP, DM-1457, DM-1431 and OPC-3952. 
     
     
         6 . The method of  claim 2 , wherein the glucuronidated aripiprazole metabolite is selected from the group consisting of DM-1454, OPC-14857 and a glucuronide of DM-1431. 
     
     
         7 . The method of  claim 2 , wherein the sulfated aripiprazole derivative is selected from the group consisting of DM-1458, DM-1460 and a sulfate of DM-1431. 
     
     
         8 . The method of  claim 1 , wherein the at least one aripiprazole metabolite comprises OPC3373. 
     
     
         9 . The method of  claim 8 , wherein the at least one aripiprazole metabolite further comprises aripiprazole. 
     
     
         10 . The method of  claim 8 , wherein the at least one aripiprazole metabolite further comprises dehydroaripiprazole. 
     
     
         11 . The method of  claim 1 , wherein the concentration of the at least one aripiprazole analyte falls outside the normal distribution of the aripiprazole analyte if the concentration is more than 2 standard deviations above or below a mean of the normal distribution. 
     
     
         12 . The method of  claim 1 , wherein the concentration of the at least one aripiprazole analyte falls outside the normal distribution of the aripiprazole analyte if the concentration is more than 1 standard deviation above or below a mean of the normal distribution. 
     
     
         13 . The method of  claim 1  further comprising recommending no modification to the aripiprazole therapy if the concentration of the at least one aripiprazole analyte falls within the normal distribution of the aripiprazole analyte. 
     
     
         14 . The method of  claim 13 , wherein the concentration of the at least one aripiprazole analyte falls within the normal distribution of the aripiprazole analyte if the concentration is no more than 2 standard deviations above or below a mean of the normal distribution. 
     
     
         15 . The method of  claim 13 , wherein the concentration of the at least one aripiprazole analyte falls within the normal distribution of the aripiprazole analyte if the concentration is no more than 1 standard deviations above or below a mean of the normal distribution. 
     
     
         16 . The method of  claim 1  further comprising normalizing the concentration of the at least one aripiprazole analyte as a function of pH, specific gravity, and/or a creatinine level associated with the urine.