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Original Research

Once-monthly paliperidone palmitate in recently diagnosed and chronic non-acute patients with schizophrenia

, , , , , , , & show all
Pages 1043-1053 | Received 08 Feb 2016, Accepted 01 Apr 2016, Published online: 09 May 2016

Figures & data

Table 1. Patient disposition.

Table 2. Patient demographics and dosing information.

Figure 1. Mean PANSS total score over time (efficacy ITT population).

***p < 0.0001 vs. baseline.†††p < 0.0001 for mean change from baseline in PANSS total score for recently diagnosed vs. chronic patients.Error bars represent 95% confidence intervals.BL: baseline; ITT: intent-to-treat; PANSS: Positive and Negative Syndrome Scale.

Figure 1. Mean PANSS total score over time (efficacy ITT population).***p < 0.0001 vs. baseline.†††p < 0.0001 for mean change from baseline in PANSS total score for recently diagnosed vs. chronic patients.Error bars represent 95% confidence intervals.BL: baseline; ITT: intent-to-treat; PANSS: Positive and Negative Syndrome Scale.

Table 3. Efficacy outcome (efficacy ITT population)*.

Figure 2. CGI–C according to proportion of patients by category over time (efficacy ITT population).

*p = 0.0320; p = 0.0008 between-group comparison, Fisher’s exact test.CGI–C: Clinical Global Impression–Change; ITT: intent-to-treat.

Figure 2. CGI–C according to proportion of patients by category over time (efficacy ITT population).*p = 0.0320; †p = 0.0008 between-group comparison, Fisher’s exact test.CGI–C: Clinical Global Impression–Change; ITT: intent-to-treat.

Table 4. Selected secondary endpoints*.

Figure 3. Functioning outcomes in non-acute schizophrenia patients. Changes in frequency distribution by PSP category over time in recently diagnosed and chronic patients.

PSP: Personal and Social Performance

Figure 3. Functioning outcomes in non-acute schizophrenia patients. Changes in frequency distribution by PSP category over time in recently diagnosed and chronic patients.PSP: Personal and Social Performance

Figure 4. Functioning outcomes in non-acute schizophrenia patients: Mini-ICF-APP domain scores* at baseline and endpoint for recently diagnosed (A, n = 218) and chronic (B, n = 325) patients.

*Change from baseline to Month 6, p < 0.0001 for all domains in both groups.Mini-ICF-APP: Mini International Classification of Functionality, Disability and Health (ICF) Rating for Activity and Participation Disorders in Psychological Illnesses.

Figure 4. Functioning outcomes in non-acute schizophrenia patients: Mini-ICF-APP domain scores* at baseline and endpoint for recently diagnosed (A, n = 218) and chronic (B, n = 325) patients.*Change from baseline to Month 6, p < 0.0001 for all domains in both groups.Mini-ICF-APP: Mini International Classification of Functionality, Disability and Health (ICF) Rating for Activity and Participation Disorders in Psychological Illnesses.

Table 5. TEAEs occurring in ≥5% of patients in any group (safety ITT population).