Methods of Identifying Schizophrenia Patients At Risk for Relapse

Abstract

The invention provides methods of identifying schizophrenia patients at risk for relapse. The invention also provides methods of early detection of schizophrenic relapse. The disclosed methods use monitoring of a subset of symptoms and/or one or more biomarkers. The symptom severity can be assessed using the Positive and Negative Syndrome Scale (PANSS) parameters. The methods of the invention can be used to provide early intervention to decrease or prevent relapse in schizophrenia patients.

1 - 22 . (canceled) 
     
     
         23 . A method of identifying a patient at risk for a schizophrenia relapse comprising
 a) measuring biomarker level in a body fluid of a patient wherein the biomarker is selected from the group consisting of IL6R, IL6 and cortisol; and   b) determining an amount of change in the biomarker level in the the body fluid of the patient as compared to a previous biomarker level in the the body fluid of the patient,   wherein an increase in the biomarker level indicates the patient is at risk for a schizophrenic relapse.   
     
     
         24 . The method of  claim 23  wherein the body fluid is blood. 
     
     
         25 . The method of  claim 23  wherein the biomarker is IL6R and the increase is at least 4 ng/ml. 
     
     
         26 . The method of  claim 23  wherein the biomarker is IL6 and the increase is at least 0.1 pg/ml. 
     
     
         27 . The method of  claim 23  wherein the biomarker is cortisol and the increase is at least 1 μg/dl. 
     
     
         28 . The method of  claim 23  further comprising administering a pharmaceutical agent to the patient to decrease likelihood of progression to the relapse or severity of the relapse. 
     
     
         29 . The method of  claim 28  wherein the pharmaceutical agent is an atypical antipsychotic. 
     
     
         30 . The method of  claim 29  wherein the atypical antipsychotic is selected from the group risperidone, paliperidone, paliperidone palimitate, olanzapine, aripiprazole, quetiapine, ziprasidone, lurasidone, asenapine, cariprazine, brexpiprazole and clozapine. 
     
     
         31 . The method of  claim 30  wherein the atypical antipsychotic is paliperidone or paliperidone palimitate. 
     
     
         32 . The method of  claim 23  wherein the patient is further assessed comprising
 a) scoring a patient on the following 7 PANSS items
 P1 (delusions) 
 P2 (conceptual disorganization) 
 P3 (hallucinations) 
 P4 (excitement) 
 P6 (suspiciousness) 
 G2 (anxiety) 
 G4 (tension) 
 
 b) determining an amount of change in the score of the 7 PANSS items as compared to a previous PANSS score for the patient, 
 wherein an increase of at least 1 point in at least 4 of the 7 PANSS items in addition to the increase in one or more biomarker levels indicates the patient is at risk for a schizophrenic relapse. 
 
     
     
         33 . The method of  claim 23  wherein the patient is further assessed comprising
 a) scoring a patient on the following 9 PANSS items
 P1 (delusions) 
 P2 (conceptual disorganization) 
 P3 (hallucinations) 
 P4 (excitement) 
 P6 (suspiciousness) 
 P7 (hostility) 
 G2 (anxiety) 
 G4 (tension) 
 G9 (unusual thought content) 
 
 b) determining an amount of change in the score of the 9 PANSS items as compared to a previous PANSS score for the patient, 
 wherein an increase of at least 1 point in at least 4 of the 9 PANSS items in addition to the increase in one or more biomarker levels indicates the patient is at risk for a schizophrenic relapse. 
 
     
     
         34 . (canceled)