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. 2011 May 15;44(2):54-72.
doi: 10.64719/pb.4064.

Efficacy and Safety of Paliperidone Extended Release 1.5 mg/day-A Double-blind, Placebo- and Active-Controlled, Study in the Treatment of Patients with Schizophrenia

Danielle Coppola  1 , Rama Melkote  1 , Caroline Lannie  1 , Jaskaran Singh  1 , Isaac Nuamah  1 , Srihari Gopal  1 , David Hough  1 , Joseph Palumbo  1
Affiliations

Efficacy and Safety of Paliperidone Extended Release 1.5 mg/day-A Double-blind, Placebo- and Active-Controlled, Study in the Treatment of Patients with Schizophrenia

Danielle Coppola et al. Psychopharmacol Bull. .

Abstract

Background: Paliperidone extended-release (paliperidone ER) is an approved oral antipsychotic medication (dosing range 3-12 mg/day) for treatment of schizophrenia and schizoaffective disorder in adults.

Methods: In this 3-arm, double-blind, placebo- and active-controlled, parallel-group study, paliperidone ER 1.5 mg was assessed to determine the lowest efficacious dose in patients (N = 201) with acute schizophrenia. Paliperidone ER 6 mg was included for assay sensitivity.

Results: Patients (intent-to-treat analysis set) had a mean age of 39.4 years; 74% were men, 43% Asian, and 40% black. The baseline mean (SD) Positive and Negative Syndrome Scale (PANSS) total score was 92.6 (13.02) and the mean (SD) change from baseline to endpoint was: placebo group, -11.4 (20.81); paliperidone ER 1.5 mg group, -8.9 (23.31); and paliperidone ER 6 mg group, -15.7 (26.25). Differences between paliperidone groups versus placebo were not significant (paliperidone ER 1.5 mg [p = 0.582], paliperidone ER 6 mg, [p = 0.308]). Safety results of paliperidone ER 1.5 mg and placebo were comparable. The most frequently reported treatment emergent adverse events (≥10%) were: placebo group-headache (15.6%) and psychotic disorder (14.1%); paliperidone ER 1.5 mg group-insomnia (13.6%); and paliperidone ER 6 mg group-headache (11.4%), insomnia (10%), and tremor (10%).

Conclusions: In this study, paliperidone ER 1.5 mg did not demonstrate efficacy in patients with acute schizophrenia. A markedly high placebo response was noted. Assay sensitivity with the 6 mg dose was not established. Paliperidone ER 1.5 mg was generally tolerable with a safety profile comparable to placebo.

Keywords: Antipsychotic; extended-release; lowest effective dose; paliperidone; schizophrenia.

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Figures

Figure 1
Figure 1
Patient Accounting
Figure 2A
Figure 2A
Change from Baseline to Endpoint in the PANSS Total Score (LOCF) (Intent-to-Treat Analysis Set)
Figure 2B
Figure 2B
Least-Squares Mean Change from Baseline in the PANSS Total score Over Time (LOCF) (Intent-to-Treat Analysis Set)
Figure 3
Figure 3
Treatment-Emergent Adverse Events Experienced by at Least 2% of Patients in Any Treatment Group (Safety Analysis Set)
See this image and copyright information in PMC

References

    1. Lublin H, Eberhard J, Levander S. Current therapy issues and unmet clinical needs in the treatment of schizophrenia: a review of the new generation antipsychotics. Int Clin Psychopharmacol. 2005;20(4):183–198. - PubMed
    1. Invega® Prescribing Information. last update July 2009. Available at http://www.janssen.com/janssen/shared/pi/invega Accessed on 18 Jan, 2010.
    1. Davidson M, Emsley R, Kramer M, Ford L, Pan G, Lim P et al. Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): results of a 6-week, randomized, placebo-controlled study. Schizophr Res. 2007;93(1-3):117–130. - PubMed
    1. Kane JM, Canas F, Kramer M, Ford L, Gassmann-Mayer C, Lim P et al. Treatment of schizophrenia with paliperidone extended-release tablets: a 6-week placebo-controlled trial. Schizophr Res. 2007;90(1-3):147–161. - PubMed
    1. Marder SR, Kramer M, Ford L, Eerdekens E, Lim P, Eerdekens M et al. Efficacy and safety of paliperidone extended-release tablets: results of a 6-week, randomized, placebo-controlled study. Biol Psychiatry. 2007;62(12):1363–1370. - PubMed

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