NCT05644301

INflammation-based Stratification for Immune-Targeted Augmentation in Major Depressive Disorder

INflammation-based Stratification for Immune-Targeted Augmentation in Major Depressive

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Universiteit Antwerpen · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomised, double-blind, placebo-controlled clinical trial in which patients with major depressive disorder will receive augmentation through minocycline (MCO), celecoxib (CXB) or placebo.

Detailed description

This project aims to repurpose two established anti-inflammatory compounds as adjuvant therapy for immune-mediated depression, in line with state-of-the-art research of the last 10 years. Immune-mediated depression represents a subtype which accounts for approximately 30% of depressive disorders. Patients with this immunosubtype are more likely to have a higher severity of depression, a lower quality of life and more somatic symptoms. Furthermore it is accompanied by a high incidence of treatment resistance. While their mechanisms of action completely differ from those of existing antidepressant treatment options, immunomodulatory drugs celecoxib and minocycline have proven their merit as add-on treatment in depressive episodes. They have been on the Belgian market for years and come with a known pharmacological and safety profile. Patient stratification at baseline based on inflammatory status will reveal which inflammatory subpopulation benefits most from each of the two investigated anti-inflammatory compounds. Additionally, our distinctive study design allows head-to-head comparison of both add-on therapies and will as such provide the last stepping stones towards clinical implementation of individualised treatment strategies in depression.

Conditions

• Major Depressive Disorder
• Inflammation

Interventions

Type	Name	Description
DRUG	Celecoxib	Oral capsule, 200 mg, twice daily, for 12 weeks
DRUG	Minocyclin	Oral capsule, 100 mg, twice daily, for 12 weeks
DRUG	Placebo	Oral capsule, no active substance, twice daily, for 12 weeks

Timeline

• Start date: 2023-09-21
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2022-12-09
• Last updated: 2024-10-15

Locations

3 sites across 1 country: Belgium