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临床试验/2024-518101-18-02
2024-518101-18-02招募中4 期

Exploring the Pharmacomicrobiomics of Depression

Radboud universitair medisch centrum Stichting1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年1月17日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
25
试验地点
1
主要终点
The primary outcomes are the association between medication induced changes in gut microbial profile, depression symptoms and side effects

研究概览

简要总结

The main aim of this project is to associate the gut microbial community and treatment efficacy (i.e., relieve in symptoms and side effects) in patients with depression.

研究设计

研究类型
Interventional

入排标准

年龄范围
18 years 至 64 years(18-64 Years)
接受健康志愿者

入选标准

  • Main diagnosis of unipolar depression
  • Indication for the prescription of an antidepressant
  • Starting a new SSRI/SNRI or TCA antidepressant treatment
  • Having already used one or more antidepressants without effect and/or with sideeffe

排除标准

  • Use of antibiotics in a period of three months prior to the baseline visit
  • Currently pregnant or breastfeeding

结局指标

主要结局

The primary outcomes are the association between medication induced changes in gut microbial profile, depression symptoms and side effects

The primary outcomes are the association between medication induced changes in gut microbial profile, depression symptoms and side effects

次要结局

  • A secondary outcome is the role of therapeutic blood plasma levels (reflecting drug absorption) in the association between medication-induced changes in the gut microbial profile and treatment efficacy.

研究者

申办方类型
Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

Mirjam Bloemendaal

Scientific

Radboud universitair medisch centrum Stichting

研究点 (1)

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Exploring the Pharmacomicrobiomics of Depression | 临床试验