NCT05648591招募中4 期
Open-label Safety Study of a 1-year 8 to 24 mg/Day Dose Regimen of Iloperidone (FANAPT®) in Adolescent Patients With Schizophrenia or Bipolar I Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period.
研究概览
简要总结
To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is willing and able to provide assent and willing to complete all aspects of the study
- •Patient's parent or legal guardian willing and able to provide consent
- •Male or female patients 12 through 17 years of age (inclusive)
- •Clinical diagnosis of either schizophrenia or bipolar I disorder
排除标准
- •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- •A positive test for drugs of abuse
研究组 & 干预措施
Iloperidone
Experimental
Open-label iloperidone
干预措施: Iloperidone (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period.
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety and Tolerability Trial of Aripiprazole IM Depot Treatment in Adult Subjects With Schizophrenia Stabilized on Oral Antipsychotics Other Than AripiprazoleSchizophreniaNCT01552772Otsuka Pharmaceutical Development & Commercialization, Inc.60
已完成
4 期
Switching From Oral Antipsychotics to Long-Acting Risperidone in Participants With SchizophreniaSchizophreniaNCT01726335Janssen-Cilag Ltd.53
已完成
4 期
Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)SchizophreniaNCT00053703University of North Carolina, Chapel Hill116
已完成
1 期
Single-dose Iloperidone Pharmacokinetics in Patients With Mild or Moderate Liver Disease, Compared to Healthy VolunteersHepatic ImpairmentNCT01529294Novartis Pharmaceuticals90
已完成
4 期
Iloperidone Augmentation of SSRIs for Patients With Major Depressive Disorder With Residual Anger and IrritabilityMajor Depressive DisorderNCT01464229Maurizio Fava, MD20