A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 522
- 试验地点
- 97
- 主要终点
- The change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at Week 6
研究概览
简要总结
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
详细描述
A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants with Schizophrenia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants between 18 to 65 years of age (inclusive) at the time of consent.
- •Participant has an identified reliable informant (eg, caregiver, relative, friend, case worker, residential treatment staff).
- •Participant is experiencing an acute exacerbation or relapse of symptoms, with onset ≤ 2 months prior to screening
- •The participant requires hospitalization for this acute exacerbation or relapse of symptoms.
- •If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening.
- •Participants who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the screening and baseline visits:
- •Participant must have a PANSS total score ≥ 80
- •Participant must have a CGI-S score ≥
- •Participants who have received previous outpatient antipsychotic treatment at an adequate dose (minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and who showed a previous good response.
排除标准
- •Sexually active participants or persons of childbearing potential who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug.
- •Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia.
- •Participant has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days prior to screening.
- •Participant has previously received SEP-363856 or was previously enrolled in a SEP-363856 clinical study
研究组 & 干预措施
SEP-363856 75 mg
SEP-363856 75 mg/day
干预措施: SEP-363856 (Drug)
Placebo
Placebo
干预措施: Placebo (Other)
SEP-363856 100 mg
SEP-363856 100 mg/day
干预措施: SEP-363856 (Drug)
结局指标
主要结局
The change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at Week 6
时间窗: Baseline to Week 6
To evaluate the efficacy of SEP-363856 (75 and 100 mg/day) compared with placebo in acutely psychotic participants with schizophrenia. PANSS total - 30-210 Higher score is indicative of greater symptomatology
The change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at Week 6
时间窗: Baseline to Week 6
To evaluate the efficacy of SEP-363856 (75 and 100 mg/day) compared with placebo in acutely psychotic participants with schizophrenia. PANSS total - 30-210 Higher score is indicative of greater symptomatology
次要结局
- Clinical Global Impression-Severity (CGI-S)(Baseline to Week 6)
- Clinical Global Impression-Severity (CGI-S)(Baseline to Week 6)