Abstract | OBJECTIVE: This study was designed to evaluate the short-term efficacy and safety of once-daily lurasidone (80 mg/day and 160 mg/day) in the treatment of an acute exacerbation of schizophrenia. METHODS: Participants, who were recently admitted inpatients with schizophrenia with an acute exacerbation of psychotic symptoms, were randomly assigned to 6 weeks of fixed-dose, double-blind treatment with lurasidone 80 mg (n=125), lurasidone 160 mg (n=121), quetiapine XR 600 mg (QXR-600 mg; n=119; active control included to test for assay sensitivity), or placebo (n=121), all dosed once daily in the evening. Efficacy was evaluated using a mixed-model repeated-measures analysis of the change from Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) total score (the primary efficacy measure) and Clinical Global Impressions severity (CGI-S) score (the key secondary efficacy measure). RESULTS: Treatment with both doses of lurasidone or with QXR-600 mg was associated with significantly greater improvement at Week 6 on PANSS total score, PANSS positive and negative subscale scores, and CGI-S score compared with placebo. The endpoint responder rate (≥ 20% improvement in PANSS total score) was higher in subjects treated with lurasidone 80 mg (65%; p<0.001), lurasidone 160 mg (79%; p<0.001), and QXR-600 mg (79%; p<0.001) compared with placebo (41%). The proportion of patients experiencing ≥ 7% weight gain was 4% for each lurasidone group, 15% for the QXR-600 mg group, and 3% for the placebo group. Endpoint changes in levels of cholesterol, triglycerides, and low-density lipoprotein ( LDL) cholesterol were comparable for both lurasidone groups and placebo, while the QXR-600 mg group showed a significant median increase compared with the placebo group in levels of cholesterol (p<0.001), LDL cholesterol (p<0.01), and triglycerides (p<0.05). CONCLUSIONS:
Lurasidone 80 mg and 160 mg doses administered once-daily in the evening, were safe and effective treatments for subjects with acute schizophrenia, with increased response rates observed at the higher dose. Dose-related adverse effects were limited, and both doses were generally well-tolerated.
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Authors | Antony Loebel, Josephine Cucchiaro, Kaushik Sarma, Lei Xu, Chuanchieh Hsu, Amir H Kalali, Andrei Pikalov, Steven G Potkin |
Journal | Schizophrenia research
(Schizophr Res)
Vol. 145
Issue 1-3
Pg. 101-9
(Apr 2013)
ISSN: 1573-2509 [Electronic] Netherlands |
PMID | 23415311
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2013 Elsevier B.V. All rights reserved. |
Chemical References |
- Antipsychotic Agents
- Dibenzothiazepines
- Isoindoles
- Thiazoles
- Quetiapine Fumarate
- Lurasidone Hydrochloride
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Topics |
- Adolescent
- Adult
- Aged
- Akathisia, Drug-Induced
- Analysis of Variance
- Antipsychotic Agents
(therapeutic use)
- Basal Ganglia Diseases
(chemically induced)
- Body Mass Index
- Body Weight
(drug effects)
- Dibenzothiazepines
(therapeutic use)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Electrocardiography
- Female
- Humans
- Isoindoles
(therapeutic use)
- Lurasidone Hydrochloride
- Male
- Middle Aged
- Models, Statistical
- Prospective Studies
- Psychiatric Status Rating Scales
- Quetiapine Fumarate
- Schizophrenia
(drug therapy)
- Severity of Illness Index
- Thiazoles
(therapeutic use)
- Time Factors
- Waist Circumference
(drug effects)
- Young Adult
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