NCT05303064招募中3 期
A Phase 3, Randomized, Double-Blind, 52-Week Study of OLZ/SAM vs Olanzapine to Evaluate Weight Gain as Assessed by Change in BMI Z-Score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (ENLIGHTEN-Youth)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 48
- 主要终点
- Change from baseline in body mass index (BMI) Zscore at week 12
研究概览
简要总结
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
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
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar I disorder, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
- •Subject is an outpatient or will be able to be treated on an outpatient basis (per Investigator judgement) by study Week 2
- •Subject has reliable family/legal guardian support available for outpatient management
- •Subject is either currently treated with olanzapine, or if treated with another antipsychotic, the subject has had an inadequate response (eg, unsatisfactory clinical response, AEs, or nonadherence to current medication) based on Investigator judgment
- •Subject must not be a danger to self or others (per Investigator judgement)
排除标准
- •Subject presents with a major depressive episode(bipolar I disorder) or other neuropsychiatric diagnosis (according to DSM-5 criteria) including schizoaffective disorder, current major depressive disorder that is untreated and/or unstable, or any other psychiatric condition that could interfere with participation in the study
- •Subject has a history of seizure disorder (exception: history of febrile seizures), severe head trauma with loss of consciousness within the 12 months prior to Screening, or other clinically significant neurological condition within the 12 months prior to Screening
- •Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale (C-SSRS)
- •Subject has received olanzapine for >= 14 days during the month prior to screening, or has a history of poor or inadequate response to treatment with olanzapine
- •Subject has taken opioid agonists within 14 days prior to Screening, or within 30 days prior to Screening (for long-acting opioid agonists)
- •Subject anticipates needing to take opioid medication during the study period (eg, planned surgery, including oral surgery)
- •Subject has taken opioid antagonists including naltrexone (any formulation) or naloxone within 60 days prior to Screening
- •Subject has used a long-acting injectable antipsychotic medication within 3 injection cycles prior to Screening
- •Subject has a BMI percentile >98th or <5th
- •Subject has a diagnosis of diabetes mellitus or presents with prediabetes lab results at Screening (hemoglobin A1c [HbA1c] >= 6%)
- •Subject has started a smoking cessation program within the 6 months prior to Screening or has joined a weight management program or has had significant changes in diet or exercise regimen within 6 weeks prior to Screening
- •Subject has participated in a clinical study of an investigational product within the last 30 days prior to Screening
研究组 & 干预措施
Group 1 OLZ/SAM
Experimental
Fixed dose combination of olanzapine and samidorphan
干预措施: OLZ/SAM (Drug)
Group 2 Olanzapine
Active Comparator
Fixed dose of olanzapine
干预措施: Olanzapine (Drug)
结局指标
主要结局
Change from baseline in body mass index (BMI) Zscore at week 12
时间窗: 12 weeks
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
次要结局
- Proportion of subjects with >=0.5 increase in BMI Z-score at Week 12(12 weeks)
- Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score for patients with schizophrenia by visit(12 weeks)
- Time to all-cause discontinuation of study drug over 52 weeks(Up to 52 weeks)
- Change from baseline in waist circumference(12 weeks)
- Change from baseline in Young Mania Rating Scale (YMRS) in patients with Bipolar I disorder(12 weeks)
- Change from baseline in Children's Depression Rating Scale-Revised (CDRS-R) for patients with bipolar I disorder by visit(12 weeks)
- Incidence of Adverse Events(Up to 52 weeks)
研究者
研究点 (48)
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