ArticleNeurology and therapy2021
Long-Term Assessment of Lurasidone in Schizophrenia: Post Hoc Analysis of a 12-Month, Double Blind, Active-Controlled Trial and 6-Month Open-Label Extension Study.
Article in Neurology and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00641745 (Long-Term Safety, Tolerability, and Effectiveness of Lurasidone in Subjects With Schizophrenia or Schizoaffective Disorder), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Long-Term Safety, Tolerability, and Effectiveness of Lurasidone in Subjects With Schizophrenia or Schizoaffective Disorder: A Randomized, Active Comparator-Controlled Trial
Who cites it
8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.
- A systematic review of the real-world effectiveness and economic and humanistic outcomes of selected oral antipsychotics among patients with schizophrenia in the United States: Updating the evidence and gaps.Journal of managed care & specialty pharmacy · 2024Pooled it
- Second-Generation Antipsychotic Drugs for Patients with Schizophrenia: Systematic Literature Review and Meta-analysis of Metabolic and Cardiovascular Side Effects.Clinical drug investigation · 2021Pooled it
- Safety and efficacy of different initial doses of lurasidone in the schizophrenia treatment: A multi-center, randomized, open-label study.World journal of psychiatry · 2025Trial
- Efficacy of lurasidone on anxiety symptoms in patients with schizophrenia: A pooled post hoc analysis of five randomized, placebo-controlled trials.PCN reports : psychiatry and clinical neurosciences · 2025Article
- Effect of lurasidone plus sulpiride on treatment efficacy, psychiatric manifestations, and quality of life among patients with schizophrenia.World journal of psychiatry · 2025Article
- Efficacy of Lurasidone in First-Episode Psychosis: Patient Phenotypes, Dosage, and Recommendations from an Expert Panel.Neurology and therapy · 2025Review
- Lurasidone induces developmental toxicity and behavioral impairments in zebrafish embryos.Frontiers in psychiatry · 2025Article
- The Role of Lurasidone in Managing Depressive Symptoms in People with Schizophrenia: A Review.Brain sciences · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionA post hoc analysis of a double-blind (DB) active control trial and an open-label extension (OLE) study was conducted to evaluate the long-term effects of lurasidone in patients with schizophrenia.
methodsIn the DB trial, patients were randomised to receive lurasidone or risperidone for 12 months. In OLE, all patients received lurasidone for an additional 6 months. Treatment-emergent adverse events (TEAEs) were evaluated. Efficacy assessments included relapse rate (DB trial only), and Positive and Negative Syndrome Scale, Clinical Global Impression-Severity scale, and Montgomery-Åsberg Depression Rating Scale.
resultsIn the DB trial, patients with schizophrenia were randomised to lurasidone (n = 399) and risperidone (n = 190), of whom 129 and 84 continued into OLE, respectively. During the DB trial, incidence of TEAEs was similar for lurasidone (84.1%) and risperidone (84.2%). Lurasidone was associated with minimal changes in metabolic variables and prolactin levels, whereas risperidone was associated with clinically significant increases in prolactin and fasting glucose levels. The proportion of patients with metabolic syndrome was significantly lower in patients treated with lurasidone versus risperidone at the end of the DB trial (25.5% vs 40.4%; p = 0.0177). During OLE, patients switching from risperidone to lurasidone experienced a reduction in weight and prolactin levels; those continuing treatment with lurasidone experienced minimal changes in metabolic variables and prolactin. At the end of OLE, the proportion of patients with metabolic syndrome was no longer significantly different between groups (23.5% vs 31.5%; p = not significant). Efficacy outcomes were generally similar between groups during the DB trial, and were maintained during OLE.
conclusionLurasidone was generally well tolerated and effective in clinically stable schizophrenia patients over the long term. Lurasidone was also generally well tolerated and maintained effectiveness over 6 months in patients switching from risperidone. Patients switching from risperidone experienced improvements in metabolic parameters and prolactin levels. These findings confirm lurasidone's long-term effectiveness and favourable metabolic profile in patients with schizophrenia.
trial registrationClinicalTrials.gov identifier NCT00641745.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.