NCT05168007Unknown3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Fixed-Dose, Phase 3 Clinical Trial Evaluating the Efficacy and Safety of WID-RGC20 3 mg/Day and 6 mg/Day in Patients With Acute Psychotic Episode of Schizophrenia
Whanin Pharmaceutical Company1 个研究点 分布在 1 个国家目标入组 342 人开始时间: 2021年11月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 342
- 试验地点
- 1
- 主要终点
- Positive And Negative Syndrome Scale(PANSS) total score
研究概览
简要总结
This Study is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Fixed-Dose, Phase 3 Clinical Trial Evaluating the Efficacy and Safety of WID-RGC20 3 mg/day and 6 mg/day in Patients with Acute Psychotic Episode of 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 19 ≤ age < 65 years
- •At least 1 year of schizophrenia diagnosed according to DSM-5 criteria(295.90)
- •At least 1 psychotic episode within 1 year
- •Current psychotic episode(acute exacerbation of schizophrenia) within 2 weeks
- •80 ≤ PANSS total score ≤ 120
- •Rating of at least 4(moderate) on at least 2 of the following 4 PANSS positive symptoms
- •CGI-S score ≥ 4
- •Patients who can be hospitalized during the screening period and at least 3 weeks of the initial double-blind treatment phase
排除标准
- •Psychiatric Criteria
- •Medical history except schizophrenia specified in protocol
- •First-episode psychosis
- •Treatment-resistant schizophrenia within 2 years
- •Positive result from the blood alcohol concentration(BAC) test or the urine drug screen(UDS)
- •Have suicide risk
- •Treatment-related Criteria
- •Electroconvulsive therapy(ECT) within 12 weeks or Previous lack of response to ECT
- •Concomitant treatment with 3 or more antipsychotics within 12 weeks
- •Treatment with flunitrazepam or LAI antipsychotics less than 1 cycle or clozapine within 24 weeks
- •Treatment with CYP3A4 inducers or potent CYP3A4 inhibitors
- •Treatment with amiodarone or systemic corticosteroids for ≥ 12 weeks within 1 year
- •Required prohibited concomitant medication during the study period
- •Prior participation in any clinical trials of Cariprazine
- •Ophthalmic medical findings or related history(ex. uncontrolled diabetes or hypertension)
- •Abnormal laboratory findings specified in protocol
- •Not suitable for any other reason, as judged by the investigator
研究组 & 干预措施
Cariprazine 3mg/day
Experimental
WID-RGC20(Cariprazine) 3 mg/day
干预措施: WID-RGC20(Cariprazine) 3mg/day (Drug)
Cariprazine 6mg/day
Experimental
WID-RGC20(Cariprazine) 6 mg/day
干预措施: WID-RGC20(Cariprazine) 6mg/day (Drug)
Placebo
Placebo Comparator
Placebo for WID-RGC20(Cariprazine) 3 mg/day or 6mg/day
干预措施: Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day (Drug)
结局指标
主要结局
Positive And Negative Syndrome Scale(PANSS) total score
时间窗: at Week 6
Change from baseline in Positive And Negative Syndrome Scale(PANSS) total score at Week 6
次要结局
- Clinical Global Impressions-Severity(CGI-S)(at Week 6)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Lumateperone for the Prevention of Relapse in Patients With SchizophreniaSchizophreniaNCT04959032Intra-Cellular Therapies, Inc.228
招募中
3 期
Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive DisorderMajor Depressive DisorderNCT05850689Intra-Cellular Therapies, Inc.470
终止
3 期
Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip OsteoarthritisOsteoarthritis, HipNCT03793010Pacira Pharmaceuticals, Inc70
已完成
3 期
Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive DisorderMajor Depressive DisorderNCT05061706Intra-Cellular Therapies, Inc.480
已完成
3 期
Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive DisorderMajor Depressive DisorderNCT04985942Intra-Cellular Therapies, Inc.485