Exploring the Pharmacomicrobiomics of Depressio

Phase 4

• Conditions: Depression; Major Depressive Disorder; 10027946

• Registration Number: NL-OMON50688
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

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
side-effects

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Treatment efficacy, defined as:<br /><br>The change in depression score from baseline to follow-up, measured using the<br /><br>Hamilton Rating Scale for Depression<br /><br>The experienced side effects at follow-up, measured using the Antidepressant<br /><br>Side-Effect Checklist (ASEC)<br /><br><br /><br>Gut-microbiota community:<br /><br>Gut microbial profiling through 16s rRNA sequencing of the faecal samples. From<br /><br>this data the following parameters will be derived:<br /><br>o Global community measures: Alpha and Beta diversity (difference between<br /><br>baseline and follow-up)<br /><br>o Compositional measures: Relative abundance (difference between baseline and<br /><br>follow-up)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Therapeutic medication levels measured from blood plasma</p><br>