A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
3期
已完成
NCT04072354
| 适应症 | Schizophrenia |
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| 分期 | 3期 |
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| 申办方 | Otsuka Pharmaceutical Development & Commercialization, Inc. |
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| 状态 | 已完成 |
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| 受试者人数 | 463 人 |
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| 干预（药物） | SEP-363856 50mg, SEP-363856 75mg |
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| 开始日期 | 2019年9月17日 |
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| 完成日期 | 2023年5月12日 |
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| 结果公布日 | 2026年5月28日 |
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摘要
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 13 years old -65 years old who have been diagnosed with schizophrenia.
Change From Baseline in PANSS Total Score at Week 6
Baseline, Week 6 · score on a scale
| Adults: Placebo | -19.3 ± 1.55 score on a scale |
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| Adults: SEP-363856 50mg | -16.9 ± 1.57 score on a scale |
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| Adults: SEP-363856 75mg | -19.6 ± 1.56 score on a scale |
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| p-value | 0.886 |
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| Least Square (LS) Mean Difference | 2.4 (95% CI -1.9–6.7) |
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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。