A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
Фаза 3
Завершено
NCT04072354
| Заболевание | Schizophrenia |
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| Фаза | Фаза 3 |
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| Спонсор | Otsuka Pharmaceutical Development & Commercialization, Inc. |
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| Статус | Завершено |
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| Участники | 463 участн. |
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| Вмешательство | SEP-363856 50mg, SEP-363856 75mg |
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| Дата начала | 17.09.2019 |
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| Дата завершения | 12.05.2023 |
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| Публикация результатов | 28.05.2026 |
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Кратко
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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