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Table 2 Efficacy assessments from baseline to end point (LOCF analysis)

From: Onset of efficacy with acute long-acting injectable paliperidone palmitate treatment in markedly to severely ill patients with schizophrenia: post hoc analysis of a randomized, double-blind clinical trial

 

Placebo, n = 83

Paliperidone palmitate

Efficacy measure

 

234/39 mg, n = 72

234/156 mg, n = 72

234/234 mg, n = 85

PANSS total score

   Baseline, mean (SD)

92.6 (9.2)

95.8 (8.9)

94.5 (7.9)

96.0 (9.2)

   LS mean (SE) change from baseline

-9.8 (2.8)

-15.4 (2.7)

-18.7 (2.8)

-20.7 (2.8)

   P value for LS mean (vs placebo)

--

0.046

0.001

<0.001

CGI-S score

   Baseline, mean (SD)

5.1 (0.3)

5.2 (0.4)

5.1 (0.2)

5.1 (0.3)

   LS mean (SE) change from baseline

-0.9 (0.2)

-1.1 (0.2)

-1.3 (0.2)

-1.5 (0.2)

   P value for LS mean (vs placebo)

--

0.387

0.023

0.003

PSP score

   Baseline, mean (SD)

42.9 (10.1)

41.3 (10.4)

44.7 (11.5)

41.0 (10.1)

   LS mean (SE) change from baseline

10.3 (2.2)

11.5 (2.1)

15.1 (2.2)

17.7 (2.2)

   P value for LS mean (vs placebo)

--

0.597

0.028

0.0005

  1. Each paliperidone palmitate subject received 234 mg of paliperidone palmitate on day 1 and then their assigned dose day 8 and monthly thereafter.
  2. CGI-S = Clinical Global Impression-Severity scale; LOCF = last-observation-carried-forward; LS = least-squares; PANSS = Positive and Negative Syndrome Scale; PSP = Personal and Social Performance.