A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
第3相
完了
NCT04092686
| 対象疾患 | Schizophrenia |
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| 相 | 第3相 |
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| スポンサー | Otsuka Pharmaceutical Development & Commercialization, Inc. |
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| ステータス | 完了 |
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| 参加者数 | 464 名 |
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| 介入（薬剤） | SEP-363856 75mg, SEP-363856 100mg |
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| 開始日 | 2019年10月14日 |
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| 完了日 | 2023年6月14日 |
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| 結果公開日 | 2026年6月18日 |
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概要
A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 18 -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 60 locations world wide. The study will last up to nine (9) weeks.
Change From Baseline in PANSS Total Score at Week 6
Baseline, Week 6 · score on a scale
| Placebo | -14.3 ± 1.47 score on a scale |
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| SEP-363856 75mg | -16.4 ± 1.49 score on a scale |
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| SEP-363856 100mg | -18.1 ± 1.50 score on a scale |
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| p-value | 0.132 |
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| Least Square (LS) Mean Difference | -2.1 (95% CI -5.7–1.5) |
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