A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
Phase 3
Completed
NCT04092686
| 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 | 464 participants |
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| Interventions | SEP-363856 75mg, SEP-363856 100mg |
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| Start date | Oct 14, 2019 |
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| Completion date | Jun 14, 2023 |
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| Results posted | Jun 18, 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 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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Open in BENITIONS
View on ClinicalTrials.gov
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