A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
3期
已完成
NCT04092686
| 适应症 | Schizophrenia |
|---|
| 分期 | 3期 |
|---|
| 申办方 | Otsuka Pharmaceutical Development & Commercialization, Inc. |
|---|
| 状态 | 已完成 |
|---|
| 受试者人数 | 464 人 |
|---|
| 干预（药物） | SEP-363856 75mg, SEP-363856 100mg |
|---|
| 开始日期 | 2019年10月14日 |
|---|
| 完成日期 | 2023年6月14日 |
|---|
| 结果公布日 | 2026年6月18日 |
|---|
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 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 |
|---|
| SEP-363856 75mg | -16.4 ± 1.49 score on a scale |
|---|
| SEP-363856 100mg | -18.1 ± 1.50 score on a scale |
|---|
| p-value | 0.132 |
|---|
| Least Square (LS) Mean Difference | -2.1 (95% CI -5.7–1.5) |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
全部试验
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。