Table 2.
Study | Population | Linking Method | Evaluation of Change | Baseline PANSS | MCIDa | |
---|---|---|---|---|---|---|
Mean (SD) | Absolute Value | Percent of Baselineb | ||||
Current Study | Single study, Multiple sites, Enrolled Schizophrenics, Excluded other psychotic disorders and first episode, inpatient/outpatient, n=1442 | EPL | change in CGI-S | 75.6 (17.6) | 15.3 | 34 |
Schennach-Wolff et al12 | Multicenter follow-up program, Enrolled all psychotic disorders, inpatient only, n=398 | EPL | CGI-I | -- | 5 | 17 |
Levine et al11 | Pooled sample of 4 drug trials, first episode, acute, chronic, Schizophrenia and Schizoaffective disorder, n=2698 | EPL | CGI-I | -- | -- | 22 |
Leucht et al14,32 | Pooled sample of 7 drug trials, Enrolled all psychotic disorders, included only hospitalized “florid” psychosis, n=4091 | EPL | CGI-I, Change in CGI-S | 94 (19) | 15 | 24 |
Cramer et al15 | Single sample at multiple VA sites, Schizophrenia resistant to at least 2 medications, n=423 | ANOVA | 5-level change scalec | 91 (15) | -- | 21 |
MCID of the PANSS as calculated by anchor based methods which link change in PANSS to a measure of global clinical change. For studies using the CGI-I, MCID estimated as the change in PANSS associated with CGI-I=3 (Minimally Improved). Reported estimates are averaged over the time periods analyzed.
The MCID as a percent change from baseline. Cramer et al15 is the only paper specifically accounting for the minimum PANSS total score of 30 points when calculating percent change.
Cramer et al15 used a 5-level clinician rated global clinical change scale.
Abbreviations: PANSS, Positive and Negative Syndrome Scale; MCID, Minimum Clinically Important Difference; SD, Standard Deviation; CGI-S, Clinical Global Impressions Scale – Severity; CGI-I, Clinical Global Impressions Scale – Improvement; EPL, Equipercentile Linking