ACTRN12618001042235已完成2 期
A Phase 2a Proof-of-Concept Study of R-107 for the Treatment of Refractory Major Depressive Disorder
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 168
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Provision of written informed consent prior to any study specific procedures;
- •2. Subjects aged 18-80 years inclusive at the time of enrolment (screening visit);
- •3. Diagnosed with MDD as per Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) and Mini-International Neuropsychiatric Interview (MINI) 7.0 without psychotic features for at least three months prior to screening (comorbid anxiety disorders are also acceptable);
- •4. Montgomery Asberg Depression Rating Scale (MADRS) total score of greater than or equal to 20 at screening and baseline;
- •5. Treatment resistance in major depression (TRD) as per Maudsley Staging Method (MSM) and defined as failure to attain significant level of improvement (equated with clinical remission) from an accurately defined depressive episode following treatment with an antidepressant medication given at an adequate (minimum effective) dose for a minimum of six weeks”;
- •6. Montreal Cognitive Assessment (MoCA) score greater than or equal to 26 assessing cognitive function;
- •7. Psychotropic medication and/or psychotherapy is stable (i.e. no change of drugs or drug dose or visit schedule within 4 weeks prior to Day 1/baseline);
- •8. Subjects must weigh at least 50kg and have a Body Mass Index (BMI) between 18 and 40 kg/m2 inclusive;
- •9. Subjects of childbearing potential (SOCBP) must use a highly effective form of birth control .
排除标准
- •1.Any significant disease or disorder (e.g., cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject’s ability to participate in the study;
- •2.Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening and at baseline, which in the opinion of the Investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject’s ability to complete entire duration of the study.
- •3.Any ECG abnormality obtained during the screening period that in Investigator’s judgement may put the subject at risk or negatively affect the outcome of the study;
- •4.Subjects are excluded if they have any of the following:
- •A history of known immunodeficiency disorder including a positive test for human immunodeficiency virus, HIV-1 or HIV-2;
- •Positive hepatitis B surface antigen, or positive hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enrol.
- •5.Hepatic Insufficiency: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level greater than or equal to 2 times the upper limit of normal (ULN) confirmed by repeated testing during screening period;
- •6.Pregnant, breastfeeding, or lactating women (Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1);
- •7.Significant current risk of suicide.
研究者
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