The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- changes in Hamilton Depression Rating Scale (HDRS)
研究概览
简要总结
The aim of this study is to investigate the effect of Gliatamin (chonline alphoscerate) on depressive mood in type 2 diabetes patients and demonstrate the impact of improved depressive mood could be influence the patient's quality of life and glycemic control.
详细描述
The prevalence of depressive disorder is higher in individuals with chronic diseases, and the screening and management of depression is emphasized. Diabetes mellitus (DM) is a class of chronic disease and the incidence of DM has been increasing. According to previous study, 31.1% of patients with DM accompanied with depressive disorders which was higher than that of subjects without DM. Furthermore, DM as well as depression is known for risk factor for dementia.
The choline metabolism involves in neuropathology of depressive disorders and individuals with depressive disorders showed the lower level of choline concentration. Choline alphoscerate is cholinergic precursor and showed the favorable clinical results in dementia management.
As pseudodementia can be presented as depressive disorder and choline alphoscerate would be an option for these cases. Therefore, the aim of this study is to investigate the effect of Gliatamin (chonline alphoscerate) on depressive mood in type 2 diabetes patients and demonstrate the impact of improved depressive mood could be influence the patient's quality of life and glycemic control.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic patients
- •Glycemic control: HbA1c ≤ 10.0%
- •10 ≤ Beck Depression Inventory (BDI) <30 points
- •Participants who can undergo contraception in case of being in childbearing period
- •Understands the study procedure, alternatives, and risks and voluntarily agrees to participate by giving written informed concent
排除标准
- •Type 1 diabetes, Secondary diabetes, gestational diabetes
- •Ongoing dementia treatment or anti-depressive disorder medication
- •Uncontrolled psychiatric disorder
- •BDI ≥ 30 points
- •Heavy alcoholics
- •Underlying chronic liver disease (hemochromatosis, liver cell carcinoma, autoimmune liver disease, liver cirrhosis, chronic viral hepatitis)
- •Allergy or hypersensitivity to target medication or any of its components
- •Renal failure, moderate or severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m2), or ongoing dialysis
- •Abnormal liver function (AST/ALT > x3 upper normal limit)
- •History of alcohol or drug abuse in the previous 3 months
- •Premenopausal women who are nursing or pregnant
- •Human immunodeficiency virus (HIV) or human immunodeficiency virus (AIDS)
- •chronic pancreatitis or pancreatic cancer
研究组 & 干预措施
Glitamin
800mg/day
干预措施: Chonline Alphoscerate (Drug)
Placebo
same shape, color, size tablet as Glitamin
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
changes in Hamilton Depression Rating Scale (HDRS)
时间窗: 6 months after the treatment
The HDRS will be scored by face-to-face interview.
次要结局
- changes in Mini-mental state examination (MMSE) score(6 months after the treatment)
- glucometabolic parameters(6 months after the treatment)