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Cited by 210Schizophrenia research and treatmentHealthcare Decision-Making and RestraintsMental Health and Psychiatry

Effect of Long-Acting Injectable Antipsychotics vs Usual Care on Time to First Hospitalization in Early-Phase Schizophrenia

Open access
Kane, John M., Schooler, Nina R., Marcy, Patricia, Correll, Christoph U., Achtyes, Eric D., Gibbons, Robert D., Robinson, Delbert G.·2020·JAMA psychiatry
DOI 10.1001/jamapsychiatry.2020.2076PMC PMC7364341
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Abstract

Importance: Long-acting injectable antipsychotics (LAIs) can potentially reduce hospitalization risk by enhancing medication adherence but are rarely considered for early-phase schizophrenia treatment. Objective: To determine whether encouraging use of a LAI compared with usual care delays the time to first hospitalization with patients with early-phase illness. Design, Setting, and Participants: The Prevention of Relapse in Schizophrenia (PRELAPSE) trial was cluster randomized with a follow-up duration of 2 years. The study began in December 2014, was completed in March 2019, and was conducted in 39 mental health centers in 19 US states. Site randomization assigned 19 clinics to encourage treatment with long-acting aripiprazole monohydrate (aripiprazole once monthly [AOM] condition) and 20 to provide treatment as usual (clinician's choice [CC] condition). Participant eligibility criteria included (1) schizophrenia diagnosis confirmed by a structured clinical interview, (2) fewer than 5 years of lifetime antipsychotic use, and (3) age 18 to 35 years. The AOM sites identified 576 potentially eligible participants, of whom 234 (40.6%) enrolled; CC sites identified 685 potentially eligible participants, of whom 255 (37.2%) enrolled. Interventions: There were no restrictions on treatment at CC sites (including using LAIs) or at AOM sites with the exception that aripiprazole monohydrate had to be prescribed within US Food and Drug Administration-approved guidelines. Main Outcomes and Measures: The primary outcome was time to first psychiatric hospitalization based on participant interviews every 2 months, the service use resource form administered every 4 months, and other sources (eg, health records) as available. Potential events were adjudicated by an independent committee masked to treatment assignment. Results: The 489 participants (368 men [75.3%]) had a mean (SD) age of 25.2 (4.2) years and 225 (46.0%) had 1 year or less lifetime antipsychotic use. Fifty-two AOM (22%) and 91 CC participants (36%) had at least 1 hospitalization. The mean survival time until first hospitalization was 613.7 days (95% CI, 582.3-645.1 days) for AOM participants and 530.6 days (95% CI, 497.3-563.9 days) for CC participants. For time to first hospitalization, the hazard ratio was 0.56 (95% CI, 0.34- 0.92; P = .02), favoring AOM. Survival probabilities were 0.73 (95% CI, 0.65-0.83) for AOM participants and 0.58 (95% CI, 0.50-0.67) for CC participants. The number needed to treat to prevent 1 additional hospitalization was 7 participants treated with AOM compared with CC. Conclusions and Relevance: Long-acting injectable antipsychotic use by patients with early-phase schizophrenia can significantly delay time to hospitalization, a personally and economically important outcome. Clinicians should more broadly consider LAI treatment for patients with early-phase illness. Trial Registration: ClinicalTrials.gov Identifier: NCT02360319.

Integrity signals

Registry

Crossref · 10.1001/jamapsychiatry.2020.2076

Cites

47 of 47 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

6 of 17 cited sources checked · 2 supported · 0 flagged · accuracy not yet measured

  • Premisecitation

    For patients with early-phase illness, second episodes of psychosis in the same individual respond less well to the same treatment than the first episode.

    “For patients with early-phase illness, an additional consequence is that prospective studies 7 report that second episodes of psychosis in the same individual respond less well to the same treatment than the first episode.”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [7] 7. Takeuchi H, Siu C, Remington G, et al. Does relapse contribute to treatment resistance? antipsychotic response in first-vs. second-episode schizophrenia. Neuropsychopharmacology. 2019; 44(6):1036-1042. doi:10.1038/s41386-018-0278-3 source

      The Abstract reports that the same patients received the same antipsychotic in both episodes and responded less well in the second. However, the Patients section says the data were collected during routine clinical care and analyzed retrospectively, so describing this paper as a prospective study is not supported. (LLM, conf=0.84)

      Experimental — accuracy not yet measured
  • Premisecitation

    Surveys of physician attitudes about LAIs show that physicians consider LAIs primarily for patients who have already had repeated hospitalizations and relapses.

    “but surveys of physician attitudes about LAIs show that they consider LAIs primarily for patients who have already had repeated hospitalizations and relapses.11”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [11] 11. Iyer S, Banks N, Roy M-A, et al. A qualitative study of experiences with and perceptions regarding long-acting injectable antipsychotics: part II-physician perspectives. Can J Psychiatry. 2013;58(5)(suppl 1):23S-29S. doi:10.1177/ 088740341305805s04 source

      Prescribing Practices Around LAIs (p. 5) reports that most physicians considered LAIs a last resort, including after multiple relapses, and the Discussion (p. 6) says they may be presented late in treatment. The paper does not establish repeated hospitalizations as a prerequisite, and its own findings come from physician focus groups rather than a survey. (LLM, conf=0.87)

      Experimental — accuracy not yet measured
  • Premisecitation

    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”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [33] 33. Csernansky JG, Mahmoud R, Brenner R; Risperidone-USA-79 Study Group. A comparison of risperidone and haloperidol for the prevention of relapse in patients with schizophrenia. N Engl J Med. 2002;346(1):16-22. doi:10.1056/NEJMoa002028 source

      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)

      Experimental — accuracy not yet measured
  • Findingown data

    Estimated survival probabilities from the Cox model were 0.73 (95% CI, 0.65-0.83) for AOM participants and 0.58 (95% CI, 0.50-0.67) for CC participants.

    “Survival probabilities were 0.73 (95% CI, 0.65-0.83)for AOM participants and 0.58 (95% CI, 0.50-0.67)for CC participants.”
    Quote in the paperSubstantial claim
  • Findingown data

    For time to first hospitalization, the hazard ratio was 0.56 (95% CI, 0.34-0.92; P = .02), favoring AOM.

    “For time to first hospitalization, the hazard ratio was 0.56 (95% CI, 0.34-0.92;P = .02),favoring AOM.”
    • Also stated in: § Primary Outcome · plain
      “Under the proportional hazards assumption, the HR for time to first hospitalization was 0.56 (95% CI, 0.34-0.92;P = .02),favoring AOM.”
    Quote in the paperSubstantial claim
    • The authors state this as an assumption: The proportional hazards assumption holds for the Cox regression model used to estimate the hazard ratio for time to first hospitalization.
  • May combine two claims. 14
  • Classified as probably not a substantial claim. 15

  • May combine two claims.

    Premisecitation

    In a small single-site study, Subotnik et al. randomly assigned 86 first-episode patients to oral or LAI risperidone and found relapse rates of 33% vs 5%.

    “Subotnick et al, 13 in a small study conducted at a single academic site, randomly assigned 86 patients with first-episode illness to receive oral or LAI risperidone and found substantially different respective relapse rates of 33% vs 5%.”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [13] 13. Subotnik KL, Casaus LR, Ventura J, et al. Long-acting injectable risperidone for relapse prevention and control of breakthrough symptoms after a recent first episode of schizophrenia. a randomized clinical trial. JAMA Psychiatry. 2015;72 (8):822-829. doi:10.1001/jamapsychiatry.2015.0270 source

  • May combine two claims.

    Premisecitation

    Although RCTs can provide the highest level of evidence, this design may selectively recruit participants who are more adherent to treatment than general patient populations.

    “Although RCTs can provide the highest level of evidence, this design may selectively recruit participants who are more adherent to treatment than general patient populations.16”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [16] 16. Kane JM, Kishimoto T, Correll CU. Assessing the comparative effectiveness of long-acting injectable vs. oral antipsychotic medications in the prevention of relapse provides a case study in comparative effectiveness research in psychiatry. J Clin Epidemiol. 2013;66(8)(suppl):S37-S41. doi:10.1016/j.jclinepi. 2013.01.012 source

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).

    Premisecitation

    It is human nature to have difficulty taking medication on a long-term basis, regardless of the illness and medication type.

    “It is human nature to have difficulty taking medication on a long-term basis, regardless of the illness and medication type.[35][36][37]”
    Quote in the paperNot a substantial claim1 of 3 sources checked
    • cites [35] 35. Correll CU, Rubio JM, Inczedy-Farkas G, Birnbaum ML, Kane JM, Leucht S. Efficacy of 42 pharmacologic cotreatment strategies added to antipsychotic monotherapy in schizophrenia: systematic overview and quality appraisal of the meta-analytic evidence. JAMA Psychiatry. 2017;74 (7):675-684. doi:10.1001/jamapsychiatry.2017.0624 source

      The Introduction discusses limited antipsychotic effectiveness in schizophrenia, and the Results compare treatment discontinuation across cotreatment strategies. Neither section addresses whether people generally have difficulty taking medication long-term regardless of illness or medication type. Searches for long-term medication adherence and nonadherence found no passage making that point. (LLM, conf=0.76)

      Experimental — accuracy not yet measured
    • cites [36] 36. Cutler DM, Everett W. Thinking outside the pillbox-medication adherence as a priority for health care reform. N Engl J Med. 2010;362(17): 1553-1555. doi:10.1056/NEJMp1002305
    • cites [37] 37. DiMatteo MR, Giordani PJ, Lepper HS, Croghan TW. Patient adherence and medical treatment outcomes: a meta-analysis. Med Care. 2002;40(9): 794-811. doi:10.1097/00005650-200209000- 00009 source

  • May combine two claims.

    Findingown data

    The AOM option was associated with a 36% decrease in rate for total hospitalizations but the difference was not statistically significant (relative risk, 0.64; 95% CI, 0.33-1.26; P = .20).

    “In the secondary measure of total number of hospitalizations, a 36% decrease was found, but that difference was not statistically significant.”
    • Also stated in: § Secondary Outcomes · plain
      “cally significant (relative risk, 0.64; 95% CI, 0.33-1.26;P = .20).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Fifty-two AOM participants (22.2%) met criteria for a first hospitalization and 91 of the CC group (36.0%).

    “Fifty-two AOM participants (22.2%) met criteria for a first hospitalization and 91 of the CC group (36.0%).”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Interpretationreasoning

    Our study required hospitalization, which generally assures a more severe level of exacerbation and provides a strong health economic rationale.

    “Our study required hospitalization, which generally assures a more severe level of exacerbation and provides a strong health economic rationale.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    With 400 participants who completed the study (ie, 200 per group), the cause-specific HR was estimated at 80% power and 5% significance level was 1.38.

    “With 400 participants who completed the study (ie, 200 per group), the cause-specific HR was estimated at 80% power and 5% significance level was 1.38.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    In the CC group, 130 participants (51%) were prescribed an LAI at some point during the study; of these, 23 were prescribed an LAI only after a first hospitalization.

    “In the CC group, 130 participants (51%) were prescribed an LAI at some point during the study; of these, 23 were prescribed an LAI only after a first hospitalization.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    Psychiatric hospitalizations included those for all psychiatric symptoms; although most of the study hospitalizations were because of psychotic symptoms, some were because of other psychiatric symptoms.

    “Second, psychiatric hospitalizations included those for all psychiatric symptoms.Although most of the study hospitalizations were because of psychotic symptoms, some were because of other psychiatric symptoms.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The mean (SD) number of total days followed up was 594.3 (250.7) for the AOM group and 573.5 (253.9) for the CC group.

    “The mean (SD) number of total days followed up was 594.3 (250.7) for the AOM group and 573.5 (253.9) for the CC group.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationreasoning

    The usual care condition allowed the use of LAIs, and the study's CC clinics had higher rates of LAI use at baseline and during the trial than US statistics would suggest.

    “First, the usual care condition allowed the use of LAIs.Clinics had to have clinical and administrative support to participate in an LAI study; therefore, not surprisingly, the study's CC clinics had higher rates of LAI use at baseline and during the trial than US statistics would suggest.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The study's CC clinics had higher rates of LAI use at baseline and during the trial than US statistics would suggest.

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    Potential events were adjudicated by an independent committee masked to treatment assignment.

    “Potential events were adjudicated by an independent committee masked to treatment assignment.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    Schreiner et al used the Csernansky criteria for relapse, which allow for a broad interpretation of worsening.

    “Schreiner et al 12 used the Csernansky criteria for relapse, 32 which allow for a broad interpretation of worsening.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [32] 32. Hedeker D, Gibbons R. Longitudinal Data Analysis. John Wiley & Sons, Inc; 2006.

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Classified as probably not a substantial claim.

    Study design and conductcitation

    The primary analysis involved a Cox regression model with a robust sandwich covariance matrix estimate to account for intracluster dependence.

    “The primary analysis involved a Cox regression model with a robust sandwich covariance matrix estimate to account for intracluster dependence.28”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [28] 28. Lee EW, Wei LJ, Amato DA. (Cox-type regression analysis for large numbers of small groups of correlated failure time observations. In:

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The study used an independent data and safety monitoring board to evaluate participant safety, the adequacy and integrity of accumulating data, and the study's ability to test the hypotheses.

    “The study used an independent data and safety monitoring board to evaluate participant safety, the adequacy and integrity of accumulating data, and the study's ability to test the hypotheses.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductown data

    Clinics were paired based on having similar site and patient population factors and randomly assigned to treatment condition based on a predetermined computer-generated randomization list.

    “Clinics were paired based on having similar site and patient population factors (eg, urban vs rural, academic vs community, and presence of first-episode treatment vs no specialized treatment) and randomly assigned to treatment condition based on a predetermined computer-generated randomization list.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    The intention-to-treat analyses included all participants who provided informed consent and met eligibility criteria that were comprehensively assessed at the first postconsent visit.

    “The intention-to-treat analyses included all participants who provided informed consent and met eligibility criteria that were comprehensively assessed at the first postconsent visit.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    Schreiner et al reported on 715 participants within 1 to 5 years of a schizophrenia diagnosis who were randomly assigned to receive LAI paliperidone vs an array of oral medications at 141 centers in 26 countries; the time to relapse was substantially longer in the LAI group.

    “Schreiner et al 12 reported on 715 participants within 1 to 5 years of a schizophrenia diagnosis who were randomly assigned to receive LAI paliperidone vs an array of oral medications at 141 centers in 26 countries.The time to relapse was substantially longer in the LAI group.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Schreiner et al 12

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • May combine two claims.

    Premisecitation

    Tiihonen et al reported that 35.7% of patients admitted for their first hospitalization with schizophrenia stopped taking their antipsychotic within 30 days of discharge and 54.3% discontinued taking antipsychotics within 60 days of discharge.

    “Tiihonen et al 8 reported that 35.7% of patients admitted for their first hospitalization with schizophrenia stopped taking their antipsychotic within 30 days of discharge and 54.3% discontinued taking antipsychotics within 60 days of discharge.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites Tiihonen et al 8

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • May combine two claims.

    Premisecitation

    Large simple trials are less likely to affect adherence as they are embedded in the delivery of care, demand little extra effort from physicians and patients, and involve 1 or 2 objective outcome measures.

    “A partial solution to this challenge is large simple trials.17 Such trials are less likely to affect adherence as they are embedded in the delivery of care, demand little extra effort from physicians and patients, and involve 1 or 2 objective outcome measures.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [17] 17. Eapen ZJ, Lauer MS, Temple RJ. The imperative of overcoming barriers to the conduct of large, simple trials. JAMA. 2014;311(14):1397-1398. doi:10. 1001/jama.2014.1030 source

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    Assessments conducted via live, 2-way video by central, masked assessors included the Brief Psychiatric Rating Scale, Clinical Global Impressions Scale, Columbia Suicide Severity Rating Scale, and Heinrichs-Carpenter Quality of Life Scale at baseline, 12 months, and 24 months.

    “Assessments conducted via live, 2-way video by central, masked assessors included a SCID-5 interview 19 (baseline only), the Brief Psychiatric Rating Scale (BPRS), 22 the Clinical Global Impressions Scale, 23 the Columbia Suicide Severity Rating Scale, 24 and the Heinrichs-Carpenter Quality of Life Scale (QLS) 25 at baseline, 12 months, and 24 months.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Training of the AOM sites was an important element in the success of patient enrollment.

    “training of the AOM sites was an important element in the success of patient enrollment”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Study design and conductnone given

    Selection effects may have occurred with the cluster randomization design.

    “Nevertheless, selection effects may have occurred with our cluster randomization design.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Interpretationnone given

    The nature of the patients and clinical sites in the overall trial suggests good generalizability.

    “The nature of the patients and clinical sites in the overall trial suggests good generalizability”
    Quote in the paperNot a substantial claim
24 of 24

  • The authors state this as an assumption.

    The proportional hazards assumption holds for the Cox regression model used to estimate the hazard ratio for time to first hospitalization.

    “Under the proportional hazards assumption, the HR for time to first hospitalization was 0.56 (95% CI, 0.34-0.92;P = .02),favoring AOM.”

  • The paper relies on this without support.

    The PRELAPSE study is the first large-scale, multisite LAI study for patients with early-phase schizophrenia conducted in the US.

    “To our knowledge, this is the first large-scale, multisite LAI study for patients with early-phase schizophrenia conducted in the US.”

  • The paper relies on this without support.

    Time to first psychiatric hospitalization is an outcome that can be verified objectively.

    “The primary outcome measure, time to first psychiatric hospitalization, is one that can be verified objectively.”

  • The paper relies on this without support.

    Using cluster randomization at the clinic level enabled training clinical staff at AOM clinics without affecting care at CC clinics.

    “Using cluster randomization at the clinic level enabled us to train the clinical staff at clinics randomized to provide LAI treatment with long-acting aripiprazole monohydrate (aripiprazole once monthly [AOM] condition) without affecting the care at clinics providing antipsychotic medication treatment as usual (clinician's choice [CC] condition).”

  • The paper relies on this without support.

    The study's CC clinics had higher rates of LAI use at baseline and during the trial than US statistics would suggest.

    “not surprisingly, the study's CC clinics had higher rates of LAI use at baseline and during the trial than US statistics would suggest.”

  • The paper relies on this without support.

    The limited assessment schedule minimizes contact with participants outside of routine clinical care.

    “Compared with most RCTs, this limited assessment schedule was designed to minimize contact with participants outside of routine clinical care.”

  • The paper relies on this without support.

    Clinicians traditionally are less likely to consider LAIs in early illness stages.

    “at a stage when clinicians traditionally are less likely to consider LAIs.”

  • The paper relies on this without support.

    There are no data suggesting differences in efficacy among second-generation LAIs regarding prevention of hospitalization.

    “however, to our knowledge, there are no data suggesting differences in efficacy among the secondgeneration LAIs regarding prevention of hospitalization.”
8 of 8

Cites

Flagged first, then by citations

Research works printed but not linked: 1

  1. First, 2012, Structured Clinical Interview for DSM-IV® Axis I Disorders (SCID-I)

Cited by

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Related

Authors
Kane, J. M., Schooler, N. R., Marcy, P., Correll, C. U., Achtyes, E. D., Gibbons, R. D., & Robinson, D. G.
Affiliations
  • Northwell Health (US)
  • SUNY Downstate Health Sciences University (US)
  • Vanguard (United States)
  • Michigan State University (US)
  • University of Chicago (US)
Corresponding author
Kane, John M.
ORCID
Venue
JAMA psychiatry
Publisher
American Medical Association (AMA)
Published
2020-12-01
Volume
77
Issue
12
Pages
1217
ISSN
2168-622X (ISSN-L)
DOI
10.1001/jamapsychiatry.2020.2076
PMC
PMC7364341
OpenAlex
W3043420940
Cited by
210
References
45
Citations by year
2026: 26 · 2025: 29 · 2024: 36 · 2023: 43 · 2022: 35 · 2021: 33 · 2020: 1
FWCI
16.76
Type
journal article
Language
en
Open access
Locations
  • JAMA Psychiatry (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (submittedVersion)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
  • Social Sciences › Psychology › Clinical Psychology › Healthcare Decision-Making and Restraints
  • Social Sciences › Arts and Humanities › Philosophy › Mental Health and Psychiatry
Keywords
long-acting injectable antipsychotics, early-phase schizophrenia, psychiatric hospitalization, medication adherence, young adults, relapse prevention, mental health service utilization, usual care
MeSH terms
Aripiprazole, Adult, Delayed-Action Preparations, Female, Follow-Up Studies, Hospitalization, Humans, Injections

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