Comparison of SGA Oral Medications and a Long-Acting Injectable SGA: The PROACTIVE Study

PROACTIVE Study

Research output: Contribution to journalArticle

41 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)449-459
Number of pages11
JournalSchizophrenia Bulletin
Volume41
Issue number2
DOIs
StatePublished - Mar 1 2015

Fingerprint

Antipsychotic Agents
Recurrence
Injections
Brief Psychiatric Rating Scale
Therapeutics
Risperidone
Symptom Assessment
Aphasia
Secondary Prevention
Psychotic Disorders
Registries
Schizophrenia
Hospitalization
Randomized Controlled Trials
Clinical Trials
Physicians

Keywords

  • Clinical trial design
  • Negative symptoms
  • Psychotic symptoms
  • Relapse prevention
  • Schizophrenia

ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

Comparison of SGA Oral Medications and a Long-Acting Injectable SGA : The PROACTIVE Study. / PROACTIVE Study.

In: Schizophrenia Bulletin, Vol. 41, No. 2, 01.03.2015, p. 449-459.

Research output: Contribution to journalArticle

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