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; Daniel R Wilson; Donna Ames; Juan Bustillo; Jim Mintz; John M Kane; PROACTIVE Study

doi:10.1093/schbul/sbu067

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

Journal article

Open access

Peer reviewed

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, …

Schizophrenia bulletin, Vol.41(2), pp.449-459

03/2015

DOI: 10.1093/schbul/sbu067

PMCID: PMC4332934

PMID: 24870446

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https://pmc.ncbi.nlm.nih.gov/articles/PMC4332934/View

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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.

Recurrence

Outcome Assessment (Health Care)

Patient Readmission

Administration, Oral

Antipsychotic Agents - adverse effects

Humans

Middle Aged

Risperidone - administration & dosage

Risperidone - pharmacology

Male

Antipsychotic Agents - administration & dosage

Injections

Risperidone - adverse effects

Adult

Female

Psychotic Disorders - drug therapy

Antipsychotic Agents - pharmacology

Schizophrenia - drug therapy

Delayed-Action Preparations

Details

Title: Subtitle: Comparison of SGA oral medications and a long-acting injectable SGA: the PROACTIVE study
Creators: Peter F Buckley - Medical College of Georgia, Georgia Regents University, Augusta, GA; pbuckley@gru.edu
Nina R Schooler - Downstate Medical Center, State University of New York, Brooklyn, NY; Feinstein Institute for Medical Research, Zucker Hillside Hospital, Glen Oaks, NY
Donald C Goff - Nathan Kline Institute, Orangeburg, NY
John Hsiao - National Institute of Mental Health, Bethesda, MD
Alexander Kopelowicz - David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA
John Lauriello - Columbia School of Medicine, University of Missouri, Columbia, MO
Theo Manschreck - Harvard Medical School, Corrigan MH Center, Beth Israel Deaconess Medical Center, Boston, MA
Alan J Mendelowitz - Feinstein Institute for Medical Research, Zucker Hillside Hospital, Glen Oaks, NY
Del D Miller - Department of Psychiatry Research, University of Iowa Carver College of Medicine, Iowa City, IA
Joanne B Severe - National Institute of Mental Health, Bethesda, MD
Daniel R Wilson - Department of Anthropology, The University of Florida College of Medicine at Jacksonville, Jacksonville, FL
Donna Ames - David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA
Juan Bustillo - Department of Psychiatry, University of New Mexico School of Medicine, Albuquerque, NM
Jim Mintz - Health Science Center, University of Texas, San Antonio, TX
John M Kane - Feinstein Institute for Medical Research, Zucker Hillside Hospital, Glen Oaks, NY
PROACTIVE Study
Resource Type: Journal article
Publication Details: Schizophrenia bulletin, Vol.41(2), pp.449-459
DOI: 10.1093/schbul/sbu067
PMID: 24870446
PMCID: PMC4332934
NLM abbreviation: Schizophr Bull
ISSN: 1745-1701
eISSN: 1745-1701
Publisher: United States
Grant note: 1 U01MH070007 / NIMH NIH HHS 1 U01MH070012 / NIMH NIH HHS 1 U01MH070008 / NIMH NIH HHS 1 U01MH070010 / NIMH NIH HHS 1 U01MH070017 / NIMH NIH HHS 1 U01MH070023 / NIMH NIH HHS 1 U01MH070016 / NIMH NIH HHS 1 U01MH070009 / NIMH NIH HHS 1U01MH070011 / NIMH NIH HHS
Language: English
Date published: 03/2015
Academic Unit: Psychiatry
Record Identifier: 9984003465602771

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