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临床试验/NCT03039842
NCT03039842Unknown3 期

Combination of Dextromethorphan and Memantine in Treating Bipolar Disorder

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年1月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

30mg dextromethorphan+valproate

干预措施: Dextromethorphan (Drug)

5 mg MM

Experimental

5mg memantine+valproate

干预措施: Memantine (Drug)

DM+MM

Experimental

dextromethorphan+memantine+ valproate

干预措施: dextromethorphan+memantine (Drug)

placebo

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ru-Band Lu

Distinguished Professor

National Cheng-Kung University Hospital

研究点 (1)

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