NCT03187769已完成3 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
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 426
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Body Weight at Week 12
研究概览
简要总结
This study will 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
详细描述
In the US adolescent subjects starting at age 16 will be enrolled. In the EU, subjects age 18 and older will be enrolled.
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
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has less than 24 weeks previous treatment with antipsychotics (cumulative; lifetime)
- •Subject treated with aripiprazole can receive an additional 1 year of treatment at ≤5 mg/day, and this treatment will not be considered as part of the 24 weeks of previous treatment with antipsychotics
- •Has less than 4 years elapse since the initial onset of active-phase of symptoms
- •Has a body mass index (BMI) of <30 kg/m^2
- •Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after the last dose of study drug
- •Subject meets the criteria for a primary diagnosis of schizophrenia, schizophreniform disorder, or bipolar I disorder
- •For bipolar I disorder, must have been experiencing an episode of acute mania within ≤14 days prior to Visit 1
- •Suitable for outpatient treatment
- •Additional criteria may apply
排除标准
- •Poses a current suicide risk
- •Has a history of poor or inadequate response to treatment with olanzapine
- •Has previously been treated with long-acting injectable antipsychotic medication within the 2 months prior to screening, or has > 6 months cumulative life use, or has received treatment with electroconvulsive therapy in their lifetime
- •Has initiated treatment with mood stabilizers (eg lithium, valproate, etc) >2 months prior to Visit 1
- •Has a positive drug screen for opioids, phencyclidine (PCP), amphetamine/methamphetamine, or cocaine
- •Has taken opioid agonists (eg, codeine, oxycodone, tramadol, morphine) within the 14 days prior to Visit 1, or has taken opioid antagonists, including naltrexone and naloxone, within 60 days prior to Visit 1
- •Taking any weight loss agents or hypoglycemic agents
- •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
- •Has joined a weight management program or had significant changes in diet or exercise regimen within the past 6 weeks
- •Has started a smoking cessation program within the past 6 months
- •Has a history of diabetes
- •Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
- •Additional criteria may apply
研究组 & 干预措施
ALKS 3831
Experimental
Coated bilayer tablet
干预措施: ALKS 3831 (Drug)
Olanzapine
Active Comparator
Coated bilayer tablet
干预措施: Olanzapine (Drug)
结局指标
主要结局
Percent Change From Baseline in Body Weight at Week 12
时间窗: Baseline and 12 weeks
The efficacy analyses were performed using the Final Analysis Set which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug
次要结局
- Change From Baseline in Waist Circumference at Week 12(Baseline and Week 12)
- Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score Within the ALKS 3831 Group at Week 12(Baseline and Week 12)
- Percentage of Subjects With ≥7% Weight Gain at Week 12(Baseline and 12 weeks)
- Number of Participants Experiencing of Adverse Events (AEs)(Up to 16 weeks)
- Percentage of Subjects With ≥10% Weight Gain at Week 12(Baseline and 12 weeks)
研究者
研究点 (1)
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