NL-OMON37668尚未招募3 期
A randomized double blind, placebo-controlled study of fluoxetine in progressive multiple sclerosis (FLUOX-PMS) - FLUOX-PMS
Prof. dr. J. de Keyser, Neurologie, UZ Brussel0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1.Signed written informed consent.
- •2.Either secondary or primary progressive MS according to the 2005 Revised McDonald criteria.
- •3.Age 25-65 years.
- •4.EDSS at baseline of 3 - 6.5 points inclusive. Disability increased in the preceding year because of steady disease progression unrelated to relapses for at least 12 months.
- •5.Ability to be compliant with the schedule of protocol assessments.
- •6.For sexually active female patients with reproductive potential, use of reliable means of contraception.
排除标准
- •1.Pregnancy or lactation
- •2.Allergy to fluoxetine
- •3.Use of fluoxetine
- •4.Use of other antidepressants, unless they can be stopped for 2 months before starting with the study medication.
- •5.Contraindication for MRI (relative exclusion criterion because patients who have a contraindication are allowed to participate).
- •6.Major depression following the DSM-IV
- •7.Other neurologic, serious psychiatric or systemic disorders that could interfere with the assessments.
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