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

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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.

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          Author and article information

          Journal
          Schizophr Bull
          Schizophrenia bulletin
          1745-1701
          0586-7614
          Mar 2015
          : 41
          : 2
          Affiliations
          [1 ] Medical College of Georgia, Georgia Regents University, Augusta, GA; pbuckley@gru.edu.
          [2 ] Downstate Medical Center, State University of New York, Brooklyn, NY; Feinstein Institute for Medical Research, Zucker Hillside Hospital, Glen Oaks, NY;
          [3 ] Nathan Kline Institute, Orangeburg, NY;
          [4 ] National Institute of Mental Health, Bethesda, MD;
          [5 ] David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA;
          [6 ] Columbia School of Medicine, University of Missouri, Columbia, MO;
          [7 ] Harvard Medical School, Corrigan MH Center, Beth Israel Deaconess Medical Center, Boston, MA;
          [8 ] Feinstein Institute for Medical Research, Zucker Hillside Hospital, Glen Oaks, NY;
          [9 ] Department of Psychiatry Research, University of Iowa Carver College of Medicine, Iowa City, IA;
          [10 ] Department of Anthropology, The University of Florida College of Medicine at Jacksonville, Jacksonville, FL;
          [11 ] Department of Psychiatry, University of New Mexico School of Medicine, Albuquerque, NM;
          [12 ] Health Science Center, University of Texas, San Antonio, TX.
          Article
          sbu067
          10.1093/schbul/sbu067
          4332934
          24870446
          d41a485c-a1e7-42df-82a4-14734bc65e86
          © The Author 2014. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com.
          History

          clinical trial design,negative symptoms,psychotic symptoms,relapse prevention,schizophrenia

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