Combination of Dextromethorphan and Memantine in Treating Bipolar Disorder
试验速览
- 阶段
- 3 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- treatment change assessed by plasma levels of cytokines (e.g., IL-6, IL-8)
研究概览
简要总结
This is a research clinical trial of double-blind, stratified randomized, parallel group, two-centre study. It will be conducted in a total of 250~300 male and female subjects from the Department of Psychiatry at National Cheng Kung University Hospital. Eligible subjects will be psychiatric out- and in-patients, aged between 18~65 years old, who have psychiatric evaluation with clinically suspected of having bipolar II disorder and fulfill the inclusion and exclusion criteria. The add-on double-blind study treatment with dextromethorphan/place will commence at randomization for while patients continue open-label valproate. Subjects will be enrolled for 12 weeks double-blind add-on treatment and randomly assigned to (1) 30mg dextromethorphan+valproate, (2) 5mg memantine+valproate, (3) dextromethorphan+memantine+valproate or (4) placebo+valproate. Concomitant benzodiazepine medication (preferably up to 8mg lorazepam) may be used for daytime sedation, agitation or insomnia during the study. For the consideration of the less influence to immune-system, resperidone 1-3mg/daily and fluoxetine maximum 20mg/daily will be chose. We will measure the treatment response and side effect to clarify the curative effect of DM and memantine add-on therapy to valproate in the treatment of bipolar disorders. This study is being performed to investigate the possibly significant beneficial effects on the subtypes of bipolar disorders psychopathology.
详细描述
A total of 250~300 male and female subjects from the Department of Psychiatry at National Cheng Kung University Hospital. Eligible subjects who are aged between 18~65 years old and clinically suspected of having bipolar II disorder are invited. The add-on double-blind study treatment with dextromethorphan/place will commence at randomization for while patients continue open-label valproate. Subjects will be enrolled for 12 weeks double-blind add-on treatment and randomly assigned to (1) 30mg dextromethorphan+valproate, (2) 5mg memantine+valproate, (3) dextromethorphan+memantine+valproate or (4) placebo+valproate. Concomitant benzodiazepine medication (preferably up to 8mg lorazepam) may be used for daytime sedation, agitation or insomnia during the study. For the consideration of the less influence to immune-system, resperidone 1-3mg/daily and fluoxetine maximum 20mg/daily will be chose. We will measure the treatment response and side effect to clarify the curative effect of DM and memantine add-on therapy to valproate in the treatment of bipolar disorders. This study is being performed to investigate the possibly significant beneficial effects on the subtypes of bipolar disorders psychopathology.
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
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A 2-day minimum for hypomania to diagnose bipolar II disorder
- •A total of Hamilton Rating Scale for Depression scored at least 18 or Young Mania Rating Scale scored at least 14 at the screening stage
- •Must allow to ensure acceptable compliance and visit
排除标准
- •Pregnant females or nursing
- •Women of childbearing potential not using adequate contraception
- •Received dextromethorphan, memantine, other antiinflammatory medication within 1 week prior
- •Clinically significant medical condition (cardiac, hepatic and renal disease)
- •Received electroconvulsive therapy patients 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
30 mg DM
30mg dextromethorphan+valproate
干预措施: Dextromethorphan (Drug)
5 mg MM
5mg memantine+valproate
干预措施: Memantine (Drug)
DM+MM
dextromethorphan+memantine+ valproate
干预措施: dextromethorphan+memantine (Drug)
placebo
Placebo+valproate
干预措施: placebo+valproate (Drug)
结局指标
主要结局
treatment change assessed by plasma levels of cytokines (e.g., IL-6, IL-8)
时间窗: baseline, week 1, week 2, week 4, week 8, week 12
change assessment
次要结局
- depression change change(baseline, week 1, week 2, week 4, week 8, week 12)
- manic state change(baseline, week 1, week 2, week 4, week 8, week 12)
研究者
Ru-Band Lu
Distinguished Professor
National Cheng-Kung University Hospital
