Abstract
BackgroundA six-item version (PANSS-6: P1=Delusions, P2=Conceptual disorganization, P3=Hallucinations, N1=Blunted Affect, N4=Social withdrawal, N6=Lack of spontaneity/flow of conversation) of the 30-item Positive and Negative Syndrome Scale (PANSS-30) has shown promise in the measurement of symptom severity in acutely exacerbated- and chronic schizophrenia, but its validity in treatment-resistant schizophrenia remains unknown. Therefore, we tested the validity and sensitivity of PANSS-6 based on data from the clozapine phase of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study.MethodsI) The scalability of PANSS-6 and PANSS-30 (i.e., whether all items provide unique information regarding syndrome severity) was tested by means of item response theory analysis ad modum Rasch; II) The correlation between PANSS-6 and PANSS-30 total scores was investigated by means of Spearman correlation analysis; III) The accuracy of PANSS-6 in identifying symptom remission was tested by comparing remission on PANSS-6 (score of ≤3 on each of the six PANSS-6 items) with remission according to the Andreasen criteria (score of ≤3 on the 8 PANSS items considered in the Andreasen criteria); and IV) The antipsychotic effect of clozapine was compared to that of olanzapine, risperidone and quetiapine using the “speed of change” on PANSS-6 and PANSS-30 (change in total score per day) as outcomes.ResultsWe found that I) only PANSS-6 and not PANSS-30 was scalable; II) The correlation between PANSS-6 and PANSS-30 total scores was high (Spearman coefficient: 0.85), III) PANSS-6 did accurately classify syndrome remission as defined by the Andreasen criteria, and IV) The only antipsychotic that resulted in improvement (speed of change significantly lower than 0 during the first three months of treatment) was clozapine, both when using PANSS-6 (speed of change: -0.072 points/day; 95%CI: -0.121, -0.024) and when using PANSS-30 (speed of change: -0.201 points/day; 95%CI: -0.400, -0.002) as outcome measures.DiscussionThese findings suggest that PANSS-6 validly measures severity, remission and antipsychotic efficacy in treatment-resistant schizophrenia.
Highlights
Lumateperone (ITI-007) is a first-in-class investigational agent in development for the treatment of schizophrenia
In all 3 studies, the primary endpoint was change from baseline on the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo
In Study ITI007-302, neither dose of lumateperone separated from placebo on the primary endpoint in the intent-to-treat population; a high placebo response was observed in this study
Summary
Schizophrenia is a severe mental disorder requiring multimodal treatment. Monitoring the severity of schizophrenia during treatment is essential to a successful outcome. The most widely used measure of the severity of schizophrenia is the 30-item Positive And Negative Syndrome Scale (PANSS-30) obtained by the Structured Clinical Interview, SCIPANSS, which takes approximately an hour to administer. This is too long for routine clinical use. The scale consists of the following items: P1 - Delusions, P2 - Conceptual disorganization, P3 - Hallucinatory behavior, N1 - Blunted Affect, N4 - Passive/apathetic social withdrawal and N6 - Lack of spontaneity & flow of conversation For it remains unknown whether it is possible to obtain sufficient information for PANSS-6 rating via a short and focused interview. Field-testing at hospitals in the United States and Denmark has shown that the patient section of SNAPSI can be completed in approximately 15–25 minutes by raters who are unfamiliar with the interview and involving patients hearing the
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