Long-Acting Injectable Risperidone for Relapse Prevention and Control of Breakthrough Symptoms After a Recent First Episode of Schizophrenia: A Randomized Clinical Trial

Subotnik, Kenneth L.; Casaus, Laurie R.; Ventura, Joseph; Luo, John S.; Hellemann, Gerhard S.; Gretchen-Doorly, Denise; Marder, Stephen; Nuechterlein, Keith H.

doi:10.1001/jamapsychiatry.2015.0270

Cited by 262Schizophrenia research and treatmentFamily Caregiving in Mental IllnessMental Health and Psychiatry

Long-Acting Injectable Risperidone for Relapse Prevention and Control of Breakthrough Symptoms After a Recent First Episode of Schizophrenia: A Randomized Clinical Trial

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Subotnik, Kenneth L., Casaus, Laurie R., Ventura, Joseph, Luo, John S., Hellemann, Gerhard S., Gretchen-Doorly, Denise, Marder, Stephen, Nuechterlein, Keith H.·2015·JAMA Psychiatry

DOI 10.1001/jamapsychiatry.2015.0270PMC PMC5065351

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Abstract

IMPORTANCE: Long-acting, injectable, second-generation antipsychotic medication has tremendous potential to bring clinical stability to persons with schizophrenia. However, long-acting medications are rarely used following a first episode of schizophrenia. OBJECTIVE: To compare the clinical efficacy of the long-acting injectable formulation of risperidone with the oral formulation in the early course of schizophrenia. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial performed at a university-based research clinic, between 2005 and 2012. Eighty-six patients with recent onset of schizophrenia were randomized to receive long-acting injectable risperidone or oral risperidone. Half of each group was simultaneously randomized to receive cognitive remediation to improve cognitive functioning or healthy-behaviors training to improve lifestyle habits and well-being. An intent-to-treat analysis was performed between October 4, 2012, and November 12, 2014. INTERVENTIONS: A 12-month trial comparing the long-acting injectable vs oral risperidone and cognitive remediation vs healthy-behaviors training. MAIN OUTCOMES AND MEASURES: Psychotic relapse and control of breakthrough psychotic symptoms. RESULTS: Of the 86 patients randomized, 3 refused treatment in the long-acting injectable risperidone group. The psychotic exacerbation and/or relapse rate was lower for the long-acting risperidone group compared with the oral group (5% vs 33%; χ21 = 11.1; P < .001; relative risk reduction, 84.7%). Long-acting injectable risperidone better controlled mean levels of hallucinations and delusions throughout follow-up (β = -0.30; t68 = -2.6, P = .01). The cognitive remediation and healthy-behaviors training groups did not differ significantly regarding psychotic relapse, psychotic symptom control, or hospitalization rates, and there were no significant interactions between the 2 medications and the 2 psychosocial treatments. Discontinuations owing to inadequate clinical response were more common in the oral group than in the long-acting risperidone group (χ21 = 6.1; P = .01). Adherence to oral risperidone did not appear to differ before randomization but was better for the long-acting risperidone group compared with the oral group (t80 = 5.3; P < .001). Medication adherence was associated with prevention of exacerbation and/or relapse (χ21 =11.1; P = .003) and control of breakthrough psychotic symptoms (β = 0.2; t79 = 2.1; P = .04). CONCLUSIONS AND RELEVANCE: The use of long-acting injectable risperidone after a first episode of schizophrenia has notable advantages for clinical outcomes. The key clinical advantages are apparently owing to the more consistent administration of the long-acting injectable. Such formulations should be offered earlier in the course of illness. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00333177.

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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%.”
From Effect of Long-Acting Injectable Antipsychotics vs Usual Care on Time to First Hospitalization in Early-Phase Schizophrenia (2020) · cites this paper as [13]

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Authors: Subotnik, K. L., Casaus, L. R., Ventura, J., Luo, J. S., Hellemann, G. S., Gretchen-Doorly, D., Marder, S., & Nuechterlein, K. H.
Affiliations: University of California, Los Angeles (US)
Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine at UCLA (University of California, Los Angeles)
ORCID: Subotnik, Kenneth L.
Ventura, Joseph
Luo, John S.
Hellemann, Gerhard S.
Marder, Stephen
Nuechterlein, Keith H.
Venue: JAMA Psychiatry
Publisher: American Medical Association (AMA)
Published: 2015-08-01
Volume: 72
Issue: 8
Pages: 822
ISSN: 2168-622X (ISSN-L)
DOI: 10.1001/jamapsychiatry.2015.0270
PMC: PMC5065351
OpenAlex: W2139645720
Semantic Scholar: 32694e85bf1b2e5f161e8aa329409402859aa721
Cited by: 262
References: 22
Citations by year: 2026: 14 · 2025: 23 · 2024: 18 · 2023: 19 · 2022: 30 · 2021: 32 · 2020: 23 · 2019: 22 · 2018: 23 · 2017: 31 · 2016: 22 · 2015: 5
FWCI: 21.89
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: JAMA Psychiatry (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
eScholarship (California Digital Library) (submittedVersion)
Funders: Janssen Scientific Affairs
National Institutes of Health (MH066286)
Genentech
National Institute of Mental Health (MH037705, MH-066286, R01MH037705, P50MH066286, NCT00333177)
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
Social Sciences › Psychology › Clinical Psychology › Family Caregiving in Mental Illness
Social Sciences › Arts and Humanities › Philosophy › Mental Health and Psychiatry
Keywords: long-acting injectable risperidone, first-episode schizophrenia, psychotic relapse, cognitive remediation, psychosocial interventions, medication adherence, hospitalization, relapse prevention, atypical antipsychotics, delusions and hallucinations, treatment discontinuation
MeSH terms: Administration, Oral, Combined Modality Therapy, Delayed-Action Preparations, Female, Humans, Male, Schizophrenia, Antipsychotic Agents, Health Behavior, Cognitive Behavioral Therapy, Treatment Outcome, Risperidone, Medication Adherence, Secondary Prevention, Young Adult, Early Medical Intervention

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Long-Acting Injectable Risperidone for Relapse Prevention and Control of Breakthrough Symptoms After a Recent First Episode of Schizophrenia: A Randomized Clinical Trial

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