Evidence map›Paper›PMID 39020362›Full record

ArticleAnnals of general psychiatry2024

Long-term safety and effectiveness of lurasidone in adolescents and young adults with schizophrenia: pooled post hoc analyses of two 12-month extension studies.

Fabrizio Calisti, Michael Tocco, Yongcai Mao, Robert Goldman

Abstract read
In one paragraph

Article in Annals of general psychiatry, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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2 · The registry

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3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

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5 · Who and what money

Authors and funding

4 authors.

Fabrizio CalistiAngelini Pharma S.P.A, Viale Amelia, 70, 00181, Rome, Italy.
Michael ToccoFormer Employee of Sumitomo Pharma America, Inc, 84 Waterford Drive, Marlborough, MA 01752, USA. mj.tocco@gmail.com.
Yongcai MaoSumitomo Pharma America, Inc, 84 Waterford Drive, Marlborough, MA, 01752, USA.
Robert GoldmanFormer Employee of Sumitomo Pharma America, Inc, 84 Waterford Drive, Marlborough, MA 01752, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesThe aim of this analysis was to evaluate the long-term safety and effectiveness of lurasidone in the treatment of schizophrenia in adolescents and young adults (13-25).

methodsThe 2 pooled studies used similar designs and outcome measures. Patients (13-25) with schizophrenia completed an initial double-blind 6-week trial of lurasidone (40 and 80 mg/day) in the adolescent trial and (80 and 160 mg/day) in the young adult trial. In open-label long-term trials, adolescent patients were treated with 20-80 mg/day lurasidone, and adults were treated with 40-160 mg/day lurasidone. Efficacy was evaluated based on the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity Scale (CGI-S).

resultsThe safety population consisted of 306 patients (mean age, 16.2 years; 208 patients (68.0%) who completed 12 months of treatment; 8.2% who discontinued treatment by 12 months due to an adverse event). The mean (SD) changes in the PANSS total score from the extension baseline to months 6 and 12 were - 11.8 (13.9) and - 15.3 (15.0), respectively (OC), and the mean (SD) changes in the CGI-S score were - 0.8 (1.0) and - 1.0 (1.1), respectively (OC). The most frequent adverse events were headache (17.6%), anxiety (11.4%), schizophrenia (9.8%), and nausea (9.8%). No clinically meaningful changes were observed in weight, metabolic parameters, or prolactin.

conclusionsIn adolescents and young adults with schizophrenia, treatment with lurasidone was generally well tolerated and effective. Long-term treatment was associated with a continued reduction in symptoms of schizophrenia. Long-term treatment was associated with minimal effects on weight, metabolic parameters, and prolactin. CLINICALTRIALS: gov identifiers D1050234, D1050302.

Indexed as

Atypical antipsychoticsLong-termLurasidoneSchizophrenia

Identifiers

PMID39020362
PMCPMC11256627

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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.