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Schizophr Res. 2018 Feb;192:185-193. doi: 10.1016/j.schres.2017.04.004. Epub 2017 Apr 26.

Paliperidone palmitate once-monthly maintains improvement in functioning domains of the Personal and Social Performance scale compared with placebo in subjects with schizoaffective disorder.

Author information

1
Janssen Research & Development, LLC, Titusville, NJ 08560, USA. Electronic address: dfu@its.jnj.com.
2
Janssen Research & Development, LLC, Titusville, NJ 08560, USA.
3
Collaborative Neuroscience Network, Inc, Garden Grove, CA, USA.
4
New York University, New York, NY, USA.
5
SUNY Downstate Medical Center, Brooklyn, NY, USA.
6
Janssen Scientific Affairs, LLC, Titusville, NJ, 08560, USA.

Abstract

OBJECTIVE:

Evaluate the effect of paliperidone palmitate once-monthly (PP1M) injectable on the specific functioning domains of the Personal and Social Performance (PSP) scale in patients with schizoaffective disorder (SCA) participating in a long-term study.

METHODS:

This study (NCT01193153) included both in- and outpatient subjects with SCA experiencing an acute exacerbation of psychotic and mood symptoms. Subjects were treated with PP1M either as monotherapy or in combination with antidepressants or mood stabilizers during a 25-week open-label (OL) phase. Stabilized subjects were randomly assigned 1:1 (PP1M or placebo) into a 15-month double-blind (DB) relapse-prevention period. Functioning of the randomized subjects during OL and DB phases was evaluated using the PSP scale (four domains: socially useful activities, personal/social relationships, self-care, and disturbing/aggressive behaviors). Three statistical approaches were utilized to analyze PSP scores to assess robustness and consistency of findings. No adjustments were made for multiplicity.

RESULTS:

334 of 667 enrolled subjects were stabilized with PP1M, randomly assigned to PP1M (n=164) or placebo (n=170) in the DB phase, and included in this analysis. Improvements in all PSP domain scores were observed during the OL phase and were maintained during the DB phase with PP1M, but decreased with placebo. Differences compared to placebo were significant in all four PSP domains during the DB phase (P≤0.008).

CONCLUSION:

The analysis in this study showed that PP1M improves functioning, as measured by the four PSP domain scores, in symptomatic subjects with SCA. Functioning was maintained compared with placebo.

KEYWORDS:

Functioning; Long term; Long-acting injectable; Paliperidone palmitate; Personal and Social Performance scale; Schizoaffective

PMID:
28454922
DOI:
10.1016/j.schres.2017.04.004
[Indexed for MEDLINE]
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