EUCTR2019-000063-24-BG进行中（未招募）1 期
A Study to Evaluate the Safety, Tolerability, and Effect of Risperidone Extended-Release Injectable Suspension (TV-46000) for Subcutaneous Use as Maintenance Treatment in Adult and Adolescent Patients with Schizophrenia - The SHINE Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 340
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Roll over patients:
- •The patient must have participated in the pivotal efficacy study (Study TV46000-CNS-30072) without experiencing relapse events and without important protocol deviations.
- •New Patients:
- •The patient has a diagnosis of schizophrenia according to the DSM-5 for >1 year (diagnosis must be reconfirmed by SCID-5) and =1 episode of relapse in the last 24 months.
- •please refer to the protocol for additional inclusion criteria
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Roll Over and New patients:
- •The patient has a current clinically significant DSM-5 diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, or amnestic or other cognitive disorders, or borderline,
- •paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
- •please refer to the protocol for additional exclusion criteria.
研究者
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