Evidence map›Paper›PMID 25999398›Full record

Trial reportJournal of psychopharmacology (Oxford, England)2015

Paliperidone palmitate in non-acute patients with schizophrenia previously unsuccessfully treated with risperidone long-acting therapy or frequently used conventional depot antipsychotics.

A Schreiner, P Bergmans, P Cherubin, S Keim, P-M Llorca, B Cosar, A Petralia, G Corrivetti, L Hargarter

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Journal of psychopharmacology (Oxford, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 6% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Paliperidone to Treat Psychotic Disorders.Neurology international · 2021
    Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
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

9 authors at 6 institutions in 5 countries.

A SchreinerEMEA Medical Affairs, Janssen Cilag GmbH, Neuss, Germany aschrein@its.jnj.com.
P BergmansBiometrics & Reporting, Janssen Cilag Benelux, Tilburg, the Netherlands.
P CherubinEMEA Medical Affairs, Janssen Cilag, Issy-les-Moulineaux, France.
S KeimGlobal Clinical Operations EMEA Medical Affairs, Janssen Cilag, Barcarena, Portugal.
P-M LlorcaCHRU Clermont-Ferrand, Hôpital Gabriel Montpied, Clermont-Ferrand, France.
B CosarGazi University Medical Faculty, Ankara, Turkey.
A PetraliaUOPI of Psychiatry, AOU Policlinico Vittorio Emanuele, Catania, Italy.
G CorrivettiUOSM Distretto D, Pontecagnano-Faiano (Sa), Italy.
L HargarterEMEA Medical Affairs, Janssen Cilag GmbH, Neuss, Germany.
Janssen (Germany) · DECentre Hospitalier Universitaire de Clermont-Ferrand · FRGazi University · TRJanssen (France) · FRJanssen (Netherlands) · NLNational Agency for New Technologies, Energy and Sustainable Economic Development · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

PALMFlexS, a prospective multicentre, open-label, 6-month, phase IIIb interventional study, explored tolerability, safety and treatment response in adults (n = 231) with non-acute but symptomatic schizophrenia switching to flexibly dosed paliperidone palmitate (PP) after unsuccessful treatment with risperidone long-acting injectable therapy (RLAT) or conventional depot antipsychotics (APs). Treatment response was measured by change in Positive and Negative Syndrome Scale (PANSS) total score from baseline (BL) to last-observation-carried-forward (LOCF) endpoint (EP). Safety and tolerability assessments included Extrapyramidal Symptom Rating Scale (ESRS) total score and treatment-emergent adverse events. Significant reductions in mean PANSS total score were observed for all groups (-7.5 to -10.6; p ⩽ 0.01 [BL to LOCF EP]). After switching to PP, more than 50% of all patients achieved ⩾20% and one-third of RLAT-treated patients even achieved ⩾50% improvement in PANSS total score. Across groups, there were significant improvements (p < 0.05) in symptom severity as measured by Clinical Global Impression-Severity (CGI-S; trend for improvement with RLAT; p = 0.0568), subjective well-being, medication satisfaction, and patient functioning with PP. PP was generally well tolerated. Clinically relevant benefits were observed in non-acute patients with schizophrenia switched from RLAT or conventional depot APs to PP.

Indexed as

Outcome Assessment, Health CareAdultAntipsychotic AgentsDelayed-Action PreparationsFemaleHumansMaleMiddle AgedPaliperidone PalmitateProspective StudiesRisperidoneSchizophreniaSeverity of Illness IndexAntipsychotic AgentsDelayed-Action PreparationsPaliperidone PalmitateRisperidoneinjectable antipsychoticNon-acutepaliperidone palmitateschizophreniaswitching

Identifiers

PMID25999398
PMCPMC4512527
OpenAlexW2127124245

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.