Overview
Sponsor-declared trial summary
Major Depressive Disorder
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.
Key facts
- Sponsor
- Radboud universitair medisch centrum Stichting
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- completed 23 Feb 2026
- Decision date (initial)
- 2025-01-17
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518101-18-02
- EudraCT number
- 2021-006510-36
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacokinetic, Efficacy, Pharmacodynamic
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.
Conditions and MedDRA coding
Major Depressive Disorder
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10081270 | Major depressive disorder | 10037175 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-518101-18-01 | Exploring the Pharmacomicrobiomics of Depression | Radboud universitair medisch centrum Stichting |
| 2024-518101-18-00 | Exploring the Pharmacomicrobiomics of Depression | Radboud universitair medisch centrum Stichting |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 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
Exclusion criteria 2
- Use of antibiotics in a period of three months prior to the baseline visit
- Currently pregnant or breastfeeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary outcomes are the association between medication induced changes in gut microbial profile, depression symptoms and side effects
Secondary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP106373763 · ATC
- Active substance
- Venlafaxine
- Route of administration
- ORAL
- Max daily dose
- 375 mg milligram(s)
- Max total dose
- 375 mg milligram(s)
- Max treatment duration
- 999 Month(s)
- Authorisation status
- Authorised
- ATC code
- N06AX16 — VENLAFAXINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Radboud universitair medisch centrum Stichting
- Sponsor organisation
- Radboud universitair medisch centrum Stichting
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Mirjam Bloemendaal
Public contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Mirjam Bloemendaal
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 25 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-518101-18-02 | 5 |
| Recruitment arrangements (for publication) | K1_blank_document_Recruitment_arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults | 6 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Fecal collection | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | D2_SmPC Venlafaxine | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-16 | Netherlands | Acceptable 2025-01-17
|
2025-01-17 |