Exploring the Pharmacomicrobiomics of Depression
- Conditions
- Major Depressive Disorder
- Registration Number
- 2024-518101-18-02
- Lead Sponsor
- Radboud universitair medisch centrum Stichting
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 25
Aged ≥ 18
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
Use of antibiotics in a period of three months prior to the baseline visit
Currently pregnant or breastfeeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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. 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.
Trial Locations
- Locations (1)
Radboud universitair medisch centrum Stichting
🇳🇱Nijmegen, Netherlands
Radboud universitair medisch centrum Stichting🇳🇱Nijmegen, NetherlandsJoost JanzingSite contact0243666495joost.janzing@radboudumc.nl