NCT06649214尚未招募3 期
A Randomized, Double-blind, Double-dummy, Positive Drug Parallel Controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 654
- 主要终点
- Proportion of subjects with ≥10% weight gain at Week 24.
研究概览
简要总结
The goal of this [clinical trial] is to [evaluate the safety and efficacy of olanzapine-samidorphan tablets] in [adults with schizophrenia]. The main question[s] it aims to answer are:
- [question 1] Olanzapine-samidorphan significantly mitigate weight gain better than olanzapine.
- [question 2] Olanzapine- samidorphan and olanzapine have similar antipsychotic efficacy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is age 18 to 55 years, inclusive.
- •Subject has a BMI of 18.0 to 30.0 kg/m2, inclusive.
- •Subject meets the DSM-5 criteria for a primary diagnosis of schizophrenia.
- •PANSS total score ≥ 70.
排除标准
- •Diagnosis of schizoaffective disorder or bipolar I or II disorder, or current, untreated or unstable major depressive disorder, or any other psychiatric condition that could interfere with participation in the study.
- •Subject poses a current suicide risk in the opinion of the investigator.
- •Subject has inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss, anorexia nervosa, or binge eating disorder.
- •Subject has a history of diabetes.
- •Subject has used olanzapine, clozapine, chlorpromazine, or thioridazine at any time during the 6 months prior to screening or long-acting injectable antipsychotic medication in the last 6 months.
- •Subject has taken opioid agonists within the 14 days prior to screening and/or anticipates a need to take opioid medication during the study period, or has taken opioid antagonists within 60 days prior to screening.
- •Subject is taking any weight loss agents or hypoglycemic agents at screening.
- •Subject has had a surgical procedure for weight loss or is planning to have liposuction during the study.
- •Subject has a clinically significant or unstable medical illness, condition, or disorder that would be anticipated to potentially compromise subject safety or adversely affect the evaluation of efficacy.
研究组 & 干预措施
Olanzapine-samidorphan
Experimental
干预措施: Olanzapine-samidorphan； (Drug)
Olanzapine
Active Comparator
干预措施: Olanzapine (Drug)
结局指标
主要结局
Proportion of subjects with ≥10% weight gain at Week 24.
时间窗: 24 weeks
Percent change from baseline in body weight at Week 24.
时间窗: 24 weeks
次要结局
未报告次要终点
研究者
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