104 Long-term Efficacy of Lurasidone in Antipsychotic-naïve vs. Antipsychotic-exposed Adolescents with Schizophrenia: Analysis of a Two-Year Study
| Autor: | Robert Goldman, Michael Tocco, Jay Hsu, Andrei Pikalov, Christoph U. Correll |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
education.field_of_study
medicine.medical_specialty Randomization Nausea business.industry medicine.medical_treatment Population Placebo medicine.disease Psychiatry and Mental health Schizophrenia Internal medicine medicine Neurology (clinical) medicine.symptom Adverse effect education Antipsychotic business Lurasidone medicine.drug |
| Zdroj: | CNS Spectrums. 25:267-268 |
| ISSN: | 2165-6509 1092-8529 |
| DOI: | 10.1017/s109285292000022x |
| Popis: | Background:Early-onset schizophrenia is characterized by greater severity and more functional impairment than adult-onset schizophrenia. Few studies have prospectively evaluated short- or long-term antipsychotic efficacy in treatment-naïve (vs. previously treated) first-episode schizophrenia. The aim of this post-hoc analysis was to evaluate the long-term efficacy of lurasidone in antipsychotic-naïve adolescents with schizophrenia.Method:Patients aged 13-17 years with schizophrenia were randomized to 6 weeks of double-blind (DB), fixed-dose treatment with lurasidone (40 mg/day or 80 mg/day) or placebo. Six-week completers were eligible to enroll in an open-label (OL), flexible dose 2-year lurasidone treatment study. Efficacy over 104 weeks of OL treatment with lurasidone was evaluated for 2 patient groups based on treatment status prior to entering the initial DB study (treatment-naïve [TN] vs. treated previously [TP]). Treatment-naïve was defined as never having received antipsychotic treatment prior to randomization. Efficacy measures included the PANSS total score and the Clinical Global Impressions-Severity (CGI-S) score. Treatment response was defined as ≥20% reduction from baseline in PANSS total score.Results:A total of 50 TN and 221 TP patients completed the 6-week DB study and entered the extension study; and 30 (60.0%) TN and 126 (57.0%) TP patients completed 104 weeks. In the ITT population of the initial DB study, treatment with lurasidone (vs. placebo) yielded larger effects at DB endpoint on the PANSS total score in the TN group (-25.0 vs. -14.4; PConclusion:In this post-hoc analysis of a 2-year OL extension study, antipsychotic-naïve adolescents with schizophrenia responded well to treatment with lurasidone at doses of 40 mg/day or 80 mg/day. TN patients achieved greater improvement than TP patients during acute treatment; and these greater treatment effects were largely maintained during 2 years of continued treatment with lurasidone.Funding Acknowledgements:Supported by funding from Sunovion Pharmaceuticals Inc |
| Databáze: | OpenAIRE |
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