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.

1 .- 16 . (canceled) 
     
     
         17 . A method of identifying a schizophrenic subject suitable for treatment with an anti-psychotic drug therapy other than aripiprazole comprising:
 (a) detecting OPC3373 levels in a urine sample obtained from the schizophrenic subject that has been prescribed a dose of at least 2 mg aripiprazole per day for at least 1 day;   (b) terminating the prescribed aripiprazole dose and administering an anti-psychotic drug therapy other than aripiprazole to the schizophrenic subject wherein the schizophrenic subject is suitable for treatment with an anti-psychotic drug therapy other than aripiprazole when the OPC3373 urine level detected in the schizophrenic subject is lower than that observed in a control subject administered the same prescribed dose regimen of aripiprazole over the same time period as the schizophrenic subject, and wherein the control subject exhibits an OP3373 urine level of at least 25 ng/mL.   
     
     
         18 . The method of  claim 17 , wherein OPC3373 urine levels are detected via LC/MSMS, LC/MS(TOF) or direct administration to a mass spectrometry. 
     
     
         19 . The method of  claim 18 , wherein direct administration comprises Rapidfire or laser diode thermal desorption (“LDTD”). 
     
     
         20 . The method of  claim 17 , wherein the schizophrenic subject has been prescribed an aripiprazole dose selected from the group consisting of 2 mg/day, 5 mg/day, 10 mg/day, 15 mg/day, 20 mg/day, or 30 mg/day. 
     
     
         21 . The method of  claim 17 , wherein the schizophrenic subject suitable for treatment with an anti-psychotic drug therapy other than aripiprazole exhibits a dehydroaripiprazole urine level that is lower than 5 ng/mL. 
     
     
         22 . The method of  claim 17 , wherein the schizophrenic subject suitable for treatment with an anti-psychotic drug therapy other than aripiprazole exhibits an aripiprazole urine level that is lower than 5 ng/mL. 
     
     
         23 . The method of  claim 17 , further comprising detecting the levels of one or more of dehydroaripiprazole, aripiprazole, and OPC-3952 in the urine of the schizophrenic subject. 
     
     
         24 . The method of  claim 23 , wherein the schizophrenic subject suitable for treatment with an anti-psychotic drug therapy other than aripiprazole exhibits a dehydroaripiprazole urine level of at least 5 ng/mL. 
     
     
         25 . The method of  claim 23 , wherein the schizophrenic subject suitable for treatment with an anti-psychotic drug therapy other than aripiprazole exhibits an aripiprazole urine level of at least 5 ng/mL. 
     
     
         26 . A method for detecting aripiprazole in a urine sample obtained from a schizophrenic subject that has been prescribed aripiprazole comprising
 detecting OPC3373 in the urine sample via LC/MSMS, LC/MS(TOF) or direct administration to a mass spectrometry,   detecting aripiprazole in the urine sample when at least 25 ng/mL of OPC3373 is detected in the urine sample.   
     
     
         27 . The method of  claim 26 , wherein direct administration comprises Rapidfire or laser diode thermal desorption (“LDTD”). 
     
     
         28 . The method of  claim 26 , wherein the urine sample exhibits a dehydroaripiprazole urine level that is lower than 5 ng/mL. 
     
     
         29 . The method of  claim 26 , wherein the urine sample exhibits an aripiprazole urine level that is lower than 5 ng/mL. 
     
     
         30 . The method of  claim 26 , further comprising detecting the levels of one or more of dehydroaripiprazole, aripiprazole, and OPC-3952 in the urine sample. 
     
     
         31 . The method of  claim 30 , wherein the urine sample exhibits a dehydroaripiprazole urine level of at least 5 ng/mL. 
     
     
         32 . The method of  claim 30 , wherein the urine sample exhibits an aripiprazole urine level of at least 5 ng/mL. 
     
     
         33 . The method of  claim 26 , wherein the schizophrenic subject has been prescribed an aripiprazole dose selected from the group consisting of 2 mg/day, 5 mg/day, 10 mg/day, 15 mg/day, 20 mg/day, or 30 mg/day. 
     
     
         34 . The method of  claim 26 , further comprising measuring the creatinine level, pH and/or specific gravity value of the urine sample. 
     
     
         35 . A method for detecting aripiprazole in a urine sample obtained from a schizophrenic subject that has been prescribed aripiprazole comprising
 detecting OPC-3952 in the urine sample via LC/MSMS, LC/MS(TOF) or direct administration to a mass spectrometry.   
     
     
         36 . The method of  claim 34 , further comprising detecting the levels of one or more of dehydroaripiprazole, aripiprazole, and OPC3373 in the urine sample.