Table 2 Primary and secondary efficacy assessments at endpoint (mITT population).

From: Efficacy and safety of once-monthly Risperidone ISM® in schizophrenic patients with an acute exacerbation

Efficacy assessment

Placebo N = 132

Risperidone ISM 75 mg N = 129

Risperidone ISM 100 mg N = 129

PANSS total score (mean change)1

 Mean baseline score (SD)

96.4 (7.21)

96.3 (8.47)

96.1 (8.42)

 LS mean change (SE), 95% CIa

−11.0 (1.56), −14.1 to −8.0

−24.6 (1.51), −27.5 to −21.6

−24.7 (1.54), −27.7 to −21.6

 Treatment difference (SE), 95% CIb

 

−13.0 (2.19), −17.3 to −8.8

−13.3 (2.21), −17.6 to −8.9

 P valuec

 

<0.0001

<0.0001

CGI-S total score (mean change)2

 Mean baseline score (SD)

4.9 (0.52)

5.0 (0.65)

4.9 (0.48)

 LS mean change (SE), 95% CIa

−0.6 (0.09), −0.8 to −0.4

−1.3 (0.09), −1.5 to −1.2

−1.3 (0.09), −1.5 to −1.2

 Treatment difference (SE), 95% CIb

 

−0.7 (0.13), −1.0 to −0.5

−0.7 (0.13), −1.0 to −0.5

 P valuec

 

<0.0001

<0.0001

CGI-I score3

 LS means (SE), 95% CI

3.3 (0.10), 3.1–3.5

2.5 (0.10), 2.3–2.7

2.5 (0.10), 2.3–2.7

 LS means difference (SE), 95% CI

 

−0.8 (0.14), −1.0 to −0.5

−0.7 (0.14), −1.0 to −0.4

 p value

 

<0.0001

<0.0001

Overall response3

 Responders, n (%)

27 (20.5)

77 (59.7)

70 (54.3)

 95% CI (%)

13.9–28.3

50.7–68.2

45.3–63.1

 Difference in proportions (%)

 

39.2

33.8

 95% CI

 

27.5 to 49.2

22.0–43.8

 P value

 

<0.0001

<0.0001

PANSS positive subscale3

 LS Means (SE), 95% CI

−4.1 (0.50), −5.1 to −3.1

−8.0 (0.49), −9.0 to −7.1

−8.7 (0.50), −9.7 to −7.8

 LS Means Difference (SE), 95% CI

 

−3.9 (0.70), −5.3 to −2.5

−4.6 (0.71), −6.0 to −3.2

 p value

 

<0.0001

<0.0001

PANSS negative subscale3

 LS means (SE), 95% CI

−1.7 (0.40), −2.5 to −0.9

−3.8 (0.38), −4.5 to −3.0

−3.7 (0.39), −4.4 to −2.9

 LS means difference (SE), 95% CI

 

−2.1 (0.55), −3.1 to −1.0

−2.0 (0.55), −3.1 to −0.9

 p value

 

<0.001

<0.001

PANSS general psychopathology subscale3

 LS means (SE), 95% CI

−5.6 (0.82), −7.2 to −4.0

−12.8 (0.79), −14.4 to −11.3

−12.4 (0.81), −14.0 to −10.8

 LS means difference (SE), 95% CI

 

−7.3 (1.13), −9.5 to −5.0

−6.8 (1.15), −9.1 to −4.6

 p value

 

<0.0001

<0.0001

  1. 1Primary efficacy endpoint.
  2. 2Key secondary efficacy endpoint.
  3. 3Secondary efficacy endpoint.
  4. CI confidence interval, CGI-I Clinical Global Impression-Improvement Scale, CGI-S Clinical Global Impression-Severity of Illness Scale, ITT Intent-to-Treat, KM Kaplan–Meier, PANSS Positive And Negative Syndrome Scale.
  5. aData were analyzed using a mixed model repeated measures (MMRM) approach.
  6. bDifference (Risperidone ISM minus placebo) in least squares mean change from baseline adjusted by Lawrence and Hung method.
  7. CHommel adjusted p value.
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