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Randomized Controlled Trial
. 2019 Jun;13(3):667-672.
doi: 10.1111/eip.12685. Epub 2018 Jul 3.

Paliperidone palmitate once-every-3-months in adults with early illness schizophrenia

Karimah S Bell Lynum  1 , Ibrahim Turkoz  2 , Edward Kim  1
Affiliations
Randomized Controlled Trial

Paliperidone palmitate once-every-3-months in adults with early illness schizophrenia

Karimah S Bell Lynum et al. Early Interv Psychiatry. 2019 Jun.

Abstract

Aim: This post hoc analysis of a double-blind (DB), randomized, placebo-controlled, relapse-prevention study evaluated the effects of paliperidone palmitate once-every-3-months (PP3M) in a subpopulation of adults with early illness schizophrenia (duration ≤5 years) from a clinical trial.

Methods: Patients received either PP3M or placebo every 3 months in the DB phase. The primary efficacy variable was time from randomization to first relapse. Symptom severity, patient functioning, and safety were also assessed.

Results: A total of 119 patients who entered the DB phase met the criteria for early illness schizophrenia (PP3M, n = 62; placebo, n = 57). PP3M significantly delayed time to relapse vs placebo (P = .035; hazard ratio, 3.08; 95% CI, 1.08-8.80). Symptomatic control and patient functioning were maintained in the PP3M group but significantly worsened in the placebo group. There were no unexpected tolerability findings.

Conclusions: PP3M reduced relapse risk and maintained symptomatic and functional improvements compared with placebo in patients with early illness schizophrenia.

Keywords: early illness; paliperidone palmitate; recently diagnosed; relapse; schizophrenia.

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Figures

Figure 1
Figure 1
Kaplan‐Meier plot of time to relapse during the double‐blind (DB) phase in patients with early illness: intention‐to‐treat (DB) analysis set. Paliperidone palmitate once‐every‐3‐months (PP3M) significantly delayed time to relapse versus placebo (P = .035; hazard ratio, 3.08; 95% CI, 1.08, 8.80)
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References

    1. Acosta, F. J. , Hernandez, J. L. , Pereira, J. , Herrera, J. , & Rodriguez, C. J. (2012). Medication adherence in schizophrenia. World Journal of Psychiatry, 2(5), 74–82. - PMC - PubMed
    1. Alphs, L. , Bossie, C. , Mao, L. , Lee, E. , & Starr, H. L. (2015). Treatment effect with paliperidone palmitate compared with oral antipsychotics in patients with recent‐onset versus more chronic schizophrenia and a history of criminal justice system involvement. Early Intervention in Psychiatry, 12(1), 55–65. - PMC - PubMed
    1. Altamura, A. C. , Aguglia, E. , Bassi, M. , Bogetto, F. , Cappellari, L. , De Giorgi, S. , … Girardi, P. (2012). Rethinking the role of long‐acting atypical antipsychotics in the community setting. International Clinical Psychopharmacology, 27(6), 336–349. - PubMed
    1. Berwaerts, J. , Liu, Y. , Gopal, S. , Nuamah, I. , Xu, H. , Savitz, A. , … Hough, D. W. (2015). Efficacy and safety of the 3‐month formulation of paliperidone palmitate vs placebo for relapse prevention of schizophrenia: a randomized clinical trial. JAMA Psychiatry, 72(8), 830–839. - PubMed
    1. Bossie, C. A. , Fu, D. J. , Sliwa, J. K. , Ma, Y. W. , & Alphs, L. (2011). Tolerability of initiation doses of once‐monthly paliperidone palmitate in patients with recently diagnosed schizophrenia in an acute treatment trial. Therapeutic Advances in Psychopharmacology, 1(4), 111–124. - PMC - PubMed

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