Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
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.

PubMed Disclaimer

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)
See this image and copyright information in PMC

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

Publication types

Substances