A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
Phase 3
Completed
NCT04072354
| Condition | Schizophrenia |
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| Phase | Phase 3 |
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| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
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| Status | Completed |
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| Enrollment | 463 participants |
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| Interventions | SEP-363856 50mg, SEP-363856 75mg |
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| Start date | Sep 17, 2019 |
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| Completion date | May 12, 2023 |
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| Results posted | May 28, 2026 |
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Summary
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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Open in BENITIONS
View on ClinicalTrials.gov
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