Stratification and Treatment in Early Psychosis Study -ASSIST

Change in Positive and Negative Syndrome Scale (PANSS) total score

Change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to 12 weeks. The minimum value is 1 and the maximum value is 7 for each item of the scale. 1. A patient meets remission criteria if none of the following items score a 4 or higher: P1, P2, P3, N1, N4, N6, G5 and G9. 2. A patient does not meet remission criteria if one or more of these items score a 4 or higher.

Change in symptoms (sub-scale scores)

Change in scores on the Positive and Negative Syndrome Scale (PANSS) positive, negative and general symptom subscales from baseline to 12 weeks. Total PANSS score: Minimum: 30 (all items scored 1); Maximum: 210 (all items scored 7). Subscale ranges: Positive Scale: 7-49; Negative Scale: 7-49; General Psychopathology Scale: 16-112. Higher PANSS scores = worse outcome; Indicate greater symptom severity. Lower PANSS scores = better outcome; Indicate fewer or less severe symptoms.

Symptomatic remission

Symptomatic remission after 12 weeks as measured using the Positive and Negative Syndrome Scale (PANSS), defined using Andreasen (2005) remission criteria. Remission is based on the following PANSS: Positive symptoms: P1, P2, P3. Negative symptoms: N1, N4, N6. General psychopathology: G5, G9.Minimum score: 1 (absent); Maximum score: 7 (extreme). Lower scores are better outcome; Higher scores are worse outcome. Andreasen, N. C., Carpenter, W. T., Jr, Kane, J. M., Lasser, R. A., Marder, S. R., \& Weinberger, D. R. (2005). Remission in schizophrenia: proposed criteria and rationale for consensus. The American journal of psychiatry, 162(3), 441-449. https://doi.org/10.1176/appi.ajp.162.3.441

Change in overall clinical impression

Change in overall clinical impression, assessed through Clinical Global Impression of Improvement and Severity (CGI-I/S) scales from baseline to 12 weeks. Clinical Global Impression of Severity (CGI-S) is rated from 1 (normal, not at all ill) to 7 (among the most extremely ill), with lower scores indicating lower illness severity. Clinical Global Impression of Improvement (CGI-I) is rated from 1 (very much improved) to 7 (very much worse), with lower scores indicating greater clinical improvement.

Change in functioning

Change in functioning, assessed through Social and Occupational Function Scale (SOFAS) from baseline to 12 weeks. Score range 1-100, the higher score means the better function

Change in overall patient impression of severity and improvement

Change in overall patient impression, assessed through Patient Global Impression of Improvement and Severity (PGI-I/S) scales from baseline to 12 weeks. The Patient Global Impression of Improvement (PGI-I) is a single question asking the patient to rate how their psychotic symptoms is now compared to the previous study visit on a scale of 1. very much better to 7. very much worse. The lower score is better in symptoms' improvement. The Patient Global Impression of Severity (PGI-S) is a single question asking the patient to rate how their psychotic symptoms is now on a scale of 1. not present to 7. very severe. The lower score is better in symptoms.