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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
Open accessAbstract
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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“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: A Randomized Clinical Trial (2020) · cites this paper as [13]
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Long-Acting Risperidone and Oral Antipsychotics in Unstable Schizophrenia
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Metadata
- 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
- Venue
- JAMA Psychiatry
- Publisher
- American Medical Association (AMA)
- Published
- 2015-08-01
- Volume
- 72
- Issue
- 8
- Pages
- 822
- ISSN
- 2168-622X (ISSN-L)
- 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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