EUCTR2017-000497-11-ES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
相关药物
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
- 250
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
- •1. Subject meets the antipsychotic treatment and duration of illness eligibility requirements dictated in the protocol
- •2.For US sites, subject is > =16 and <40 years of age at Screening. For
- •subjects > =16 and <18 years of age, must have had previous
- •antipsychotic exposure. For European sites, subject is > =18 and <40
- •years of age at screening
- •3. Subject agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration, unless surgically sterile or post-menopausal
- •4. Subject meets the criteria for a primary diagnosis of schizophrenia, schizophreniform disorder, or bipolar I disorder
- •5. For subjects with bipolar I disorder, they must be currently experiencing an episode of acute mania
- •6. Subject is suitable for eventual outpatient treatment based on the opinion of the investigator and review of medical and clinical history by the sponsor (or designee)
- •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 250
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject poses a current suicide risk at Visit 1 or Visit 2
- •2. Subject has a history of using olanzapine or has a history of poor or inadequate response to treatment with olanzapine
- •3. Subject has previously been treated with long-acting injectable antipsychotic medication or has received treatment with electroconvulsive therapy in their lifetime
- •4. Subject is currently treated with mood stabilizers (eg, lithium, valproate, etc) at Visit 1
- •5. Subject has a positive drug screen for opioids, phencyclidine (PCP), amphetamine/ methamphetamine, or cocaine at Visit 1 or Visit 2
- •6. Subject 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
- •7. Subject is taking any weight loss agents or hypoglycemic agents at Visit 1
- •8. 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
- •9. Subject has joined a weight management program or had significant changes in diet or exercise regimen within the 6 weeks prior to Visit 1
- •10. Subject has started a smoking cessation program within the 6 months prior to Visit 1
- •11. Subject has a history of diabetes
- •12. Subject is currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
研究者
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