EUCTR2017-000497-11-DE进行中（未招募）1 期
A Study to Evaluate the Effect of ALKS 3831 Compared to Olanzapine on Body Weight in Young Adults with Schizophrenia, Schizophreniform, or Bipolar I Disorder Who are Early in Their Illness
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Alkermes Inc
- 入组人数
- 425
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
- •For US sites, men and women =16 through <40 years of age at Screening.
- •For European non-US sites, men and women =18 through <40 years of age at Screening. Subjects will have a body-mass index (BMI) of <30.0 kg/m2 at Screening and Visit 2, with a Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) primary diagnosis of schizophrenia, schizophreniform disorder, or bipolar I disorder and meet Sponsor criteria for previous antipsychotic treatment and duration of illness. Subjects with bipolar I disorder must have been experiencing an acute episode of mania as defined by DSM-5 within the last 14 days prior to Visit 1.
- •Please refer to the protocol for full list of 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 425
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects may be excluded based on diagnosis of additional psychiatric conditions, use of prohibited or contraindicated drugs and medications, pre-existing medical conditions, abnormal lab results during Screening, participation in any recent clinical trials or previous clinical trials of ALKS 3831 or samidorphan, pregnancy and relationship to an employee of the study Sponsor, CRO, Investigator, or study site.
- •Please refer to the protocol for full list of Exclusion Criteria
研究者
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