jRCTs061200006已完成不适用
2-panel, Double-blind, Randomized, Multicenter study to Evaluate the Drug blood concentration, Efficacy and Safety of D-Beta hydroxybutyrate in Healty male volunteer and Patients with Depression
未提供0 个研究点目标入组 416 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 416
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Healthy male volunteer (Part A)
- •20 to 60 years old Japanese male
- •Subject who was judged healthy by investigator
- •Subject who have a regular diet
- •Depression patient (Part B)
- •20 years old above male or female
- •At the start of the screening visit, patient must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for depression
- •Patient must administer less than 2 antidepressant with optimum dose within 28 days of enrollment, and must be stable of depression symptom and meet the depression symptom severity (MADRS total score greater than or equal to 22) at the enrollment.
- •Patient who have a regular diet
- •Patient must be medically stable on the basis of assessment and observation performed in the screening visit
- •Patient give informed consent
排除标准
- •Healty male volunteer (Part A)
- •Subject have history of drug sensitivity
- •Subject who had other study drug, non-approved and pff-label drug within 3 months before enrollment
- •Subject who donate blood
- •Subject who have surgery that might influence the drug absorption
- •Subject with drug addict or alcohol abuse
- •Subject have history of sychiatric disease
- •Subject with excessive alcohol drinking and smoking
- •Subject with allergy to pineapple
- •Subject who have a carbohydrate-restricted diet
- •Subject who do not agree to refrain from excessive exercise during the study drug administration
- •Subject who or whose partners are unwilling to agree to practice appropriate contraception during the study period
- •Depression patient (Part B)
- •Patient with moderate or higher infection
- •Patient with is drug addic
- •Patient have history of suicidal ideation or suicide attempt
- •Patient who adminster anti-inflammatory drug, immune-suppressing drug or steroid
- •Patient with malignancy
- •Patient with severe organ disorder (cardiovascular disturbance, liver and kidney)
- •Patient with diabetes
- •Patient with dementia or sychiatric disease other than depression
- •Patient with allergy to pineapple
- •Patient who have a carbohydrate-restricted diet
- •Subject who do not agree to refrain from excessive exercise during the study drug administration
- •Patient who are preg nant or nursing or who desire to become pregnant during the study period. Patients who or whose partners are unwilling to agree to practice appropriate contraception during the study period
- •Patient who had other study drug, non-approved and pff-label drug within 3 months before enrollment
结局指标
主要结局
-
Change in MADRS Total Score as Measured by the Change From Baseline to the end of the 8-Week
次要结局
未报告次要终点
研究者
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