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Cited by 605Schizophrenia research and treatmentBipolar Disorder and TreatmentMental Health and Psychiatry

A comparison of risperidone and haloperidol for the prevention of relapse in patients with schizophrenia.

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Csernansky, John G., Mahmoud, Ramy, Brenner, Ronald·2002·New England Journal of Medicine
DOI 10.1056/nejmoa002028
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Abstract

BACKGROUND: Prevention of relapse is a major goal of maintenance treatment in patients with psychotic disorders. We performed a long-term comparison of a newer, atypical antipsychotic drug, risperidone, and an older, conventional neuroleptic drug, haloperidol, in terms of the rate of relapse in patients with schizophrenia and schizoaffective disorder. METHODS: In a double-blind, prospective study at 40 sites, we randomly assigned adult outpatients in stable condition with chronic schizophrenia or schizoaffective disorder to receive treatment with flexible doses of either risperidone or haloperidol for a minimum of one year. RESULTS: Of the 397 patients who underwent randomization, data from 2 were excluded because they did not receive study medication; data from all 30 patients from one site were excluded by the sponsor, the Janssen Research Foundation, because of concern about the integrity of the data. The median duration of treatment was 364 days in the risperidone group and 238 days in the haloperidol group (P=0.02). Of the 177 patients assigned to risperidone and the 188 assigned to haloperidol who remained in the analysis, 44.1 percent and 52.7 percent, respectively, discontinued treatment for reasons other than relapse. The Kaplan-Meier estimate of the risk of relapse at the end of the study was 34 percent for the risperidone group and 60 percent for the haloperidol group (P<0.001); the risk ratio for relapse with haloperidol, from the Cox model, was 1.93 (95 percent confidence interval, 1.33 to 2.80; P<0.001). Early discontinuation of treatment for any reason was more frequent among haloperidol-treated patients (risk ratio, 1.52; 95 percent confidence interval, 1.18 to 1.96). Patients in the risperidone group had greater reductions in the mean severity of both psychotic symptoms and extrapyramidal side effects than those in the haloperidol group. CONCLUSIONS: Adult outpatients with clinically stable schizophrenia or schizoaffective disorder have a lower risk of relapse if they are treated with risperidone than if they are treated with haloperidol.

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  • To the authors' knowledge, this is the only large-scale US trial in first-episode and early-phase schizophrenia conducted primarily in community mental health centers in addition to academic settings with a more pragmatic than explanatory design.

    “To our knowledge, it is the only large-scale trial conducted in the US with first-episode and patients with early-phase schizophrenia conducted primarily in community mental health centers in addition to academic settings with a more pragmatic than explanatory design.33”

    From Effect of Long-Acting Injectable Antipsychotics vs Usual Care on Time to First Hospitalization in Early-Phase Schizophrenia (2020) · cites this paper as [33]

    The Results report a large trial of 397 patients at 40 sites. But the Patients section describes clinically stable people already receiving antipsychotic medication, not a trial specifically of first-episode or early-phase schizophrenia. The paper also does not establish that its sites were primarily community mental health centers, that its design was more pragmatic than explanatory, or that it was the only such US trial (page numbers unavailable in our copy). (LLM, conf=0.88)

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Research works printed but not linked: 2

  1. [22]22. Chouinard G, Ross-Chouinard A, Annable L, Jones BD. Extrapyram- idal Symptom Rating Scale. Can J Neurol Sci 1980;7:233. abstract.
  2. [24]24. Hogarty GE, Ulrich RF. The limitations of antipsychotic medication on schizophrenia relapse and adjustment and the contributions of psycho- social treatment. J Psychiatr Res 1998;32:243-50.

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Authors
Csernansky, J. G., Mahmoud, R., & Brenner, R.
Affiliations
Washington University in St. Louis (US)
ORCID
Mahmoud, Ramy
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2002-01-03
Volume
346
Issue
1
Pages
16-22
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa002028
OpenAlex
W2081069399
Semantic Scholar
522e423ca7d976452f217fdb1a8dd5ecd9ccbd25
Cited by
605
References
28
Citations by year
2026: 5 · 2025: 9 · 2024: 11 · 2023: 6 · 2022: 10 · 2021: 16 · 2020: 10 · 2019: 16 · 2018: 6 · 2017: 7 · 2016: 19 · 2015: 19 · 2014: 19 · 2013: 20 · 2012: 23
FWCI
42.86
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Eli Lilly and Company
  • Pfizer
  • AstraZeneca
  • Pfizer Pharmaceuticals
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
  • Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
  • Social Sciences › Arts and Humanities › Philosophy › Mental Health and Psychiatry
Keywords
risperidone, haloperidol, schizophrenia, schizoaffective disorder, relapse prevention, maintenance therapy, atypical antipsychotics, conventional neuroleptics, treatment discontinuation, extrapyramidal symptoms, psychotic symptoms
MeSH terms
Adult, Female, Haloperidol, Humans, Male, Middle Aged, Patient Compliance, Risk, Schizophrenia, Antipsychotic Agents, Proportional Hazards Models, Disease-Free Survival, Risperidone, Secondary Prevention

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