Using Memantine in Treating Bipolar Disorder Comorbid With Alcoholism
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- plasma BDNF change
研究概览
简要总结
Since memantine may not only inhibit overactivity of microglial cell, but also repair the damaged neurons and neurogenesis through activation of astroglial cell and release of neurotrophic factors, the investigators propose that the neurotrophic effect of memantine may benefit neurodegenerative diseases including bipolar disorders (BP) and alcohol dependence. In the current study, the investigator will investigate whether add-on memantine at a dose of 5 mg/day has a beneficial effect on BP comorbid with alcohol dependence.
详细描述
Each individual enter into this project will receive regulate treatment adding-on memantine medication. During each visit, patients will receive evaluation for their symptoms and plasma Brain-Derived Neurotropic Factor (BDNF), cytokines (e.g.., Interleukin-6(IL-6), IL-8) and neuropsychological performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient aged ≧18 and ≦65 years.
- •Signed informed consent by patient or legal representative.
- •The Chinese version of the modified Structural Interview of Affective Disorder and Schizophrenia-L(SADS-L), a semi-structured interview aimed at formulating the main bipolar II diagnoses based upon DSM-IV-TR criteria
- •A 2-day minimum for hypomania to diagnose BP.
- •Patient or a reliable caregiver was expected to ensure acceptable compliance and visit attendance for the duration of the study.
排除标准
- •Females who are pregnant or nursing.
- •Women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for duration of study.
- •Patient has received memantine, other anti-inflammatory medication within 1 week prior to first dose of double-blind medication, such as cyclo-oxygenase 2 (Cox-2) inhibitors.
- •Clinically significant medical condition e.g., cardiac, hepatic and renal disease with current evidence of poor controlled.
- •Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to the first dose of double-blind medication.
- •Increase in total SGOT, SGPT, BUN and creatinine by more than 3X upper limit of normal.
研究组 & 干预措施
add-on memantine therapy
add-on memantine treatment
干预措施: Memantine (Drug)
结局指标
主要结局
plasma BDNF change
时间窗: baseline, week1, week2, week4, week8, week12
treatment response change assessed by plasma BDNF
次要结局
- attention change(baseline, 12-week)
- Side effect change(baseline, week1, week2, week4, week8, week12)
- cytokine level change(baseline, week1, week2, week4, week8, week12)
研究者
Ru-Band Lu
Distinguished Professor
National Cheng-Kung University Hospital