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Neuropsychiatric Disease and Treatment Volume 17, 2021 - Issue
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Clinical Trial Report

Safety and Effectiveness of Lurasidone in Patients with Schizophrenia: A 12-Week, Open-Label Extension Study

Masaomi Iyo1 Department of Psychiatry, Graduate School of Medicine, Chiba University, Chiba, JapanORCID Iconhttps://orcid.org/0000-0002-5384-857XView further author information
ORCID Icon,
Jun Ishigooka2 Institute of CNS Pharmacology, Tokyo, JapanView further author information
,
Masatoshi Nakamura3 Department of Data Science, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, JapanORCID Iconhttps://orcid.org/0000-0002-6100-5417View further author information
ORCID Icon,
Reiko Sakaguchi4 Department of Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, JapanView further author information
,
Keisuke Okamoto5 Department of Clinical Operation, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, JapanView further author information
,
Yongcai Mao6 Division of Data Science, Sunovion Pharmaceuticals Inc., Fort Lee, NJ, USAView further author information
,
Joyce Tsai7 Division of Clinical Research, Sunovion Pharmaceuticals Inc., Fort Lee, NJ, USAView further author information
,
Alison Fitzgerald8 Division of Clinical Operations, Sunovion Pharmaceuticals Inc., Fort Lee, NJ, USAView further author information
,
Kentaro Takai9 Medical Affairs, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, JapanCorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0001-6105-4502View further author information
ORCID Icon &
Teruhiko Higuchi10 Japan Depression Center, Tokyo, Japan;11 National Center of Neurology and Psychiatry, Tokyo, JapanView further author information
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Pages 2683-2695 | Published online: 16 Aug 2021

Figures & data

Figure 1 Patient disposition.

Abbreviation: PI, principal investigator.
Figure 1 Patient disposition.

Table 1 Demographics and Open-Label Baseline Characteristics of Patients in the Open-Label Treatment Period (Safety Population)

Table 2 Summary of Adverse Events That Occurred in at Least 2% of Subjects in the Overall Population (Safety Population)

Table 3 Mean (SD) Change from Open-Label Baseline to Week 12 in Weight, BMI, Laboratory Parameters, and ECG Parameters (Safety Population)

Figure 2 PANSS total score – mean change from double-blind baseline over time (Intent-to-treat population).

Notes: Total-lurasidone = lurasidone 40 mg/day or placebo during 6-week double-blind study followed by lurasidone (flexibly dosed) during 12-week open-label study. Lurasidone-lurasidone = lurasidone 40 mg/day during 6-week double-blind study followed by lurasidone (flexibly dosed) during 12-week open-label study. Placebo-lurasidone = placebo during 6-week double-blind study followed by lurasidone (flexibly dosed) during 12-week open-label study.
Abbreviations: DB, double-blind; OL, open-label; LOCF, last observation carried forward.
Figure 2 PANSS total score – mean change from double-blind baseline over time (Intent-to-treat population).

Figure 3 PANSS total score in Japanese subpopulation – mean change from double-blind baseline over time.

Notes: Total-lurasidone = lurasidone 40 mg/day or placebo during 6-week double-blind study followed by lurasidone (flexibly dosed) during 12-week open-label study. Lurasidone-lurasidone = lurasidone 40 mg/day during 6-week double-blind study followed by lurasidone (flexibly dosed) during 12-week open-label study. Placebo-lurasidone = placebo during 6-week double-blind study followed by lurasidone (flexibly dosed) during 12-week open-label study.
Abbreviations: DB, double-blind; OL, open-label; LOCF, last observation carried forward.
Figure 3 PANSS total score in Japanese subpopulation – mean change from double-blind baseline over time.

Table 4 Mean (SD) Change from Double-Blind and Open-Label Baseline to LOCF Endpoint in Secondary Efficacy Measures (ITT Population)

Figure 4 Time from open-label baseline to all-cause discontinuation-Kaplan–Meier Plot (Intent-to-treat population).

Notes: r = number of patients at risk at that time point. Total-lurasidone = lurasidone 40 mg/day or placebo during 6-week double-blind study followed by lurasidone (flexibly dosed) during 12-week open-label study. Lurasidone-lurasidone = lurasidone 40 mg/day during 6-week double-blind study followed by lurasidone (flexibly dosed) during 12-week open-label study. Placebo-lurasidone = placebo during 6-week double-blind study followed by lurasidone (flexibly dosed) during 12-week open-label study.
Figure 4 Time from open-label baseline to all-cause discontinuation-Kaplan–Meier Plot (Intent-to-treat population).

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