Table 3.
Estimated path coefficients and corresponding percentage effect on PANSS Negative Symptom Factor Score (path analysis ITT population; n = 1274)
| Paliperidone ER vs placebo
|
||||||
|---|---|---|---|---|---|---|
| 3 mg (n = 120) | 6 mg (n = 224) | 9 mg (n = 243) | 12 mg (n = 238) | 15 mg (n = 112) | Combined (n = 937) | |
| Direct effect (%) | −1.405 (52) | −1.173 (41) | −0.760 (33) | −0.612 (21) | −0.805 (28) | −0.891 (33) |
| Indirect, change in positive symptoms (%) | −0.934 (35) | −1.259 (44) | −1.107 (49) | −1.870 (64) | −1.620 (56) | −1.387 (51) |
| Indirect, change in anxiety/depression symptoms (%) | −0.351 (13) | −0.446 (15) | −0.527 (23) | −0.527 (18) | −0.500 (17) | −0.504 (18) |
| Indirect, change in EPS (%) | −0.004 (0.14) | −0.003 (0.11) | 0.115 (−5) | 0.085 (−2.9) | 0.046 (−1.6) | 0.058 (−2.1) |
| Total effect of treatment on change in negative symptoms | −2.694 | −2.881 | −2.279 | −2.923 | −2.888 | −2.723 |
| r2 estimate | 0.350 | 0.388 | 0.333 | 0.422 | 0.345 | 0.420 |
| GFI | 0.8897 | 0.8850 | 0.8746 | 0.8849 | 0.8843 | 0.8895 |
Notes: The r2 estimate represents the proportion of the total variation of changes in negative symptoms that is explained by the treatment effect. The GFI is analogous to a squared multiple correlation; it indicates the proportion of the observed covariance explained by the model covariance. The GFI varies from 0 to 1, with 1 being a perfect fit.
Abbreviations: EPS, extrapyramidal symptoms; ER, extended-release; GFI, Goodness of Fit Index; PANSS, Positive and Negative Syndrome Scale; ITT, intent-to-treat.