Evidence map›Paper›PMID 31515972›Full record

Trial reportEarly intervention in psychiatry2020

Evaluation of paliperidone palmitate long-acting injectable antipsychotic therapy as an early treatment option in patients with schizophrenia.

Brianne Brown, Ibrahim Turkoz, Branislav Mancevski, Maju Mathews

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Early intervention in psychiatry, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01515423 (A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01515423 phase3completednot on this map

A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia

TypeinterventionalSponsorJanssen Research & Development, LLCRan2012 to 2015Enrolled1,429ConditionsSchizophreniaArmsPP3M 175 mg eq., PP3M 263 mg eq., PP3M 350 mg eq., PP3M 525 mg eq., Placebo (20% Intralipid)
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  15. Long-acting injectable antipsychotics: choosing the right dose.Journal of psychiatry & neuroscience : JPN · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Brianne BrownJanssen Scientific Affairs, LLC, Titusville, New Jersey.ORCID 0000-0002-5856-6344
Ibrahim TurkozJanssen Research and Development, LLC, Titusville, New Jersey.
Branislav MancevskiJanssen Scientific Affairs, LLC, Titusville, New Jersey.
Maju MathewsJanssen Research and Development, LLC, Titusville, New Jersey.

Funding

Janssen Scientific Affairs, LLC
6 · The paper itself

Abstract

aimThis exploratory post hoc analysis of a randomized, double-blind (DB), multicentre, non-inferiority study (NCT01515423) evaluated the effects of the long-acting injectable antipsychotic therapies once-monthly paliperidone palmitate (PP1M) and once-every-3-months paliperidone palmitate (PP3M) on symptom severity and functional remission in patients with schizophrenia with differing durations of illness (≤5, 6-10 and >10 years).

methodsEndpoints included Personal and Social Performance (PSP) scale and Positive and Negative Syndrome Scale (PANSS) total scores during the DB phase (DB baseline and DB endpoint) and the proportion of patients meeting PSP or PANSS remission criteria at any time during the open-label (OL) or DB phases that were maintained for ≥3, ≥6, ≥9 or ≥12 months.

resultsIn both the OL and DB phases, significant improvements in PSP scale and PANSS scores were observed from baseline in all duration-of-illness groups, with significantly greater improvements observed in the ≤5-year and 6-10-year groups compared with the >10-year group. The proportion of patients who maintained PSP or PANSS remission criteria for ≥3, ≥6, ≥9 and ≥12 months was higher in the ≤5-year and 6-10-year groups than in the >10-year group. Safety profiles were similar across duration-of-illness groups in the DB phase.

conclusionsSymptomatic and functional improvements were observed with PP1M/PP3M in patients with differing durations of schizophrenia, but the magnitude of the effects was greater in those with early illness vs chronic illness. These findings advocate implementation of PP1M and PP3M in all stages of schizophrenia, including early illness.

Indexed as

AdolescentAdultAgedAntipsychotic AgentsDelayed-Action PreparationsDouble-Blind MethodDrug Administration ScheduleEarly Medical InterventionFemaleHumansMaleMiddle AgedPaliperidone PalmitateSchizophreniaTime FactorsYoung AdultAntipsychotic AgentsDelayed-Action PreparationsPaliperidone Palmitateantipsychotic medicationearly illnesslong-acting injectablepaliperidone palmitateschizophrenia

Identifiers

PMID31515972
PMCPMC7384107

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.