Evidence map›Paper›PMID 24870446›Full record

Trial reportSchizophrenia bulletin2015

Comparison of SGA oral medications and a long-acting injectable SGA: the PROACTIVE study.

Peter F Buckley, Nina R Schooler, Donald C Goff, John Hsiao, Alexander Kopelowicz, John Lauriello, Theo Manschreck, Alan J Mendelowitz, Del D Miller, Joanne B Severe and 6 more

Registry-linked trialOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Schizophrenia bulletin, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00330863 (Preventing Relapse), which is not on this map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 pooled it
6.6field-weighted citation impact, top 3% 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.

NCT00330863 phase4completednot on this map

Preventing Relapse: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE)

TypeinterventionalSponsorNorthwell HealthRan2006 to 2011Enrolled357ConditionsSchizophrenia, Schizoaffective DisorderArmsRisperidone microspheres, Risperidone, Olanzapine, Quetiapine, Ziprasidone
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 3 syntheses or guidelines pooled it, 71 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guidelines for the Pharmacotherapy of Schizophrenia in Adults.Canadian journal of psychiatry. Revue canadienne de psychiatrie · 2017
    Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Observational
  14. Comparative Efficacy and Safety of Long-acting Injectable and Oral Second-generation Antipsychotics for the Treatment of Schizophrenia: A Systematic Review and Meta-analysis.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2018
    Review
  15. Article
  16. Article
  17. Review
  18. Access to Addiction Pharmacotherapy in Private Health Plans.Journal of substance abuse treatment · 2016
    Article
  19. Article
  20. 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

16 authors at 13 institutions in 2 countries.

Peter F BuckleyMedical College of Georgia, Georgia Regents University, Augusta, GA; pbuckley@gru.edu.
Nina R SchoolerDownstate Medical Center, State University of New York, Brooklyn, NY; Feinstein Institute for Medical Research, Zucker Hillside Hospital, Glen Oaks, NY;
Donald C GoffNathan Kline Institute, Orangeburg, NY;
John HsiaoNational Institute of Mental Health, Bethesda, MD;
Alexander KopelowiczDavid Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA;
John LaurielloColumbia School of Medicine, University of Missouri, Columbia, MO;
Theo ManschreckHarvard Medical School, Corrigan MH Center, Beth Israel Deaconess Medical Center, Boston, MA;
Alan J MendelowitzFeinstein Institute for Medical Research, Zucker Hillside Hospital, Glen Oaks, NY;
Del D MillerDepartment of Psychiatry Research, University of Iowa Carver College of Medicine, Iowa City, IA;
Joanne B SevereNational Institute of Mental Health, Bethesda, MD;
Daniel R WilsonDepartment of Anthropology, The University of Florida College of Medicine at Jacksonville, Jacksonville, FL;
Donna AmesDavid Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA;
Juan BustilloDepartment of Psychiatry, University of New Mexico School of Medicine, Albuquerque, NM;
Jim MintzHealth Science Center, University of Texas, San Antonio, TX.
John M KaneFeinstein Institute for Medical Research, Zucker Hillside Hospital, Glen Oaks, NY;
PROACTIVE Study
Feinstein Institute for Medical Research · USUniversity of California System · USBeth Israel Deaconess Medical Center · USFlorida College · USGeorgia Regents Medical Center · USNathan Kline Institute for Psychiatric Research · USNational Institute of Mental Health · USNational Institutes of Health · USThe University of Texas Health Science Center at San Antonio · USUniversity of Iowa · USUniversity of Missouri · USUniversity of New Mexico · USZucker Hillside Hospital · US

Funding

Relapse Prevention: Long-Acting Atypical AntipsychoticsU01MH070010 · NIMH · UNIVERSITY OF IOWA · PI MILLER, DEL D · 2006 to 2010
$1.7M
Relapse Prevention: Long-Acting Atypical AntipsychoticsU01MH070012 · NIMH · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI KOPELOWICZ, ALEX J · 2006 to 2010
$1.5M
Relapse Prevention: Long-Acting Atypical AntipsychoticsU01MH070011 · NIMH · AUGUSTA UNIVERSITY · PI BUCKLEY, PETER F · 2006 to 2010
$1.5M
Relapse Prevention: Long-Acting Atypical AntipsychoticsU01MH070007 · NIMH · FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH · PI MENDELOWITZ, ALAN · 2006 to 2010
$1.3M
Relapse Prevention: Long-Acting Atypical AntipsychoticsU01MH070016 · NIMH · CREIGHTON UNIVERSITY · PI WILSON, DANIEL R · 2006 to 2010
$1.0M
Relapse Prevention: Long Acting Atypical AntipsychoticsU01MH070008 · NIMH · UNIVERSITY OF NEW MEXICO · PI BUSTILLO, JUAN RICARDO · 2006 to 2010
$1.0M
Relapse Prevention: Long Acting Atypical AntipsychoticsU01MH070017 · NIMH · HARVARD MEDICAL SCHOOL · PI MANSCHRECK, THEO C · 2006 to 2010
$992k
Relapse Prevention: Long-Acting Atypical AntipsychoticsU01MH070009 · NIMH · MASSACHUSETTS GENERAL HOSPITAL · PI GOFF, DONALD C. · 2006 to 2010
$959k
Relapse Prevention Study: Steering and ImplementationU01MH070023 · NIMH · FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH · PI SCHOOLER, NINA R · 2006 to 2010
$724k
NIMH NIH HHS 1 U01MH070007NIMH NIH HHS 1 U01MH070008NIMH NIH HHS 1 U01MH070009NIMH NIH HHS 1 U01MH070010NIMH NIH HHS 1U01MH070011NIMH NIH HHS 1 U01MH070012NIMH NIH HHS 1 U01MH070016NIMH NIH HHS 1 U01MH070017NIMH NIH HHS 1 U01MH070023
6 · The paper itself

Abstract

Until relatively recently, long-acting injectable (LAI) formulations were only available for first-generation antipsychotics and their utilization decreased as use of oral second-generation antipsychotics (SGA) increased. Although registry-based naturalistic studies show LAIs reduce rehospitalization more than oral medications in clinical practice, this is not seen in recent randomized clinical trials. PROACTIVE (Preventing Relapse Oral Antipsychotics Compared to Injectables Evaluating Efficacy) relapse prevention study incorporated efficacy and effectiveness features. At 8 US academic centers, 305 patients with schizophrenia or schizoaffective disorder were randomly assigned to LAI risperidone (LAI-R) or physician's choice oral SGAs. Patients were evaluated during the 30-month study by masked, centralized assessors using 2-way video, and monitored biweekly by on-site clinicians and assessors who knew treatment assignment. Relapse was evaluated by a masked Relapse Monitoring Board. Differences between LAI-R and oral SGA treatment in time to first relapse and hospitalization were not significant. Psychotic symptoms and Brief Psychiatric Rating Scale total score improved more in the LAI-R group. In contrast, the LAI group had higher Scale for Assessment of Negative Symptoms Alogia scale scores. There were no other between-group differences in symptoms or functional improvement. Despite the advantage for psychotic symptoms, LAI-R did not confer an advantage over oral SGAs for relapse or rehospitalization. Biweekly monitoring, not focusing specifically on patients with demonstrated nonadherence to treatment and greater flexibility in changing medication in the oral treatment arm, may contribute to the inability to detect differences between LAI and oral SGA treatment in clinical trials.

Indexed as

Outcome Assessment, Health CareAdministration, OralAdultAntipsychotic AgentsDelayed-Action PreparationsFemaleHumansInjectionsMaleMiddle AgedPatient ReadmissionPsychotic DisordersRecurrenceRisperidoneSchizophreniaAntipsychotic AgentsDelayed-Action PreparationsRisperidoneclinical trial designnegative symptomspsychotic symptomsrelapse preventionschizophrenia

Identifiers

PMID24870446
PMCPMC4332934
OpenAlexW2105929907

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.