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Exploring the Pharmacomicrobiomics of Depression

Exploring the Pharmacomicrobiomics of Depression - Pharma-biome

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50688
Enrollment
25
Registered
2021-12-20
Start date
2021-12-12
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression Major Depressive Disorder

Interventions

Patients have a prescription for an antidepressant in the class SSRI/SNRI or TCA, prescribed as a part of regular care. Patients will start the treatment after the second (baseline) visit, after the

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Therapeutic medication levels measured from blood plasma

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)