An Open-Label Pilot Study Evaluating the Safety and Antidepressant Effects of Rellidep (BI= Biological Isolate) in Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- 50% improvement on Hamilton Depression Rating Scale-17 at 8 weeks
研究概览
简要总结
The investigators hypothesize that Rellidep will be effective in improving the symptoms of major depression. The available evidence strongly suggests that Rellidep contains a mood altering ingredient or ingredients. This open-label, non-randomized study sets out to validate its potential antidepressant activity.The study will include secondary aims of evaluating the effect of Rellidep on reducing symptoms of anxiety, a common symptom associated symptom of depression and improving quality of life.
About twenty-five patients with major depressive disorder will be assigned to open-label Rellidep (2000 mg/day) for a period of 8 weeks. All patients will be assessed by various measures of global improvement, depression, quality of life, sexual experience, anxiety and measures of side effects as well as standard laboratory tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent obtained.
- •Males/Females 20-65 years of age who require a new or a new change in their medication treatment for diagnosed major depression.
- •A clinical diagnosis fulfilling DSM-IVTR criteria for Major Depressive Disorder, single episode or recurrent.
- •17-Item Hamilton Depression Rating Scale (HAMD 17-item) total score at baseline of 18 or higher
排除标准
- •Clinical diagnosis of depression other than DSM-IVTR Major Depressive Disorder (single episode/recurrent, e.g. chronic depression and/or refractory depression are excluded).
- •Judged to be at significant risk for suicide or having a history suggesting significant current potential for self harm.
- •Antidepressant medication (other than the index antidepressant).
- •Women who are pregnant or breast-feeding or intending to become pregnant in the next 12 months.
- •Clinically significant organ system diseases, e.g. cardiovascular, hepatic, renal, endocrine, gastrointestinal, metabolic, or other systemic diseases.
- •Course of electroconvulsive therapy (ECT) during the observational period.
- •Suffer from a major neurological condition (i.e., Parkinson's disease, Huntington's disease), cerebrovascular disease (i.e., stroke), metabolic conditions (i.e., Vitamin B12 deficiency), autoimmune conditions (i.e., systematic lupus erythematosus), viral or other infections (i.e., hepatitis, mononucleosis, human immunodeficiency), and cancer.
- •Current diagnosis of Schizophrenia or other psychotic disorders (including Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, brief psychotic disorders, psychotic disorder due to general medical condition, substance induced psychotic, psychotic disorder not otherwise specified) as defined in the DSM-IV.
- •(Sub) clinical hypo/hyper thyroidism (e.g. elevated TSH).
结局指标
主要结局
50% improvement on Hamilton Depression Rating Scale-17 at 8 weeks
时间窗: 8 weeks
次要结局
- UKU(8 weeks)
- Hamilton rating scale for Anxiety (HAM-A)at 8 weeks(8 weeks)
- Montgomery Asberg Depression Rating Scale (MADRS) at 8 weeks(8 weeks)
- Clinical Global Impression-Severity and Improvement(8 weeks)
- Beck Depression Inventory Scale (BDI) a t 8 weeks(8 weeks)
- Medical Outcomes Study Short-Form 36 (SF-36)at 8 weeks(8 weeks)