RecruitingPhase 3NCT05644301

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

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


Sponsor

Universiteit Antwerpen

Enrollment

240 participants

Start Date

Sep 21, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether an anti-inflammatory add-on treatment can help people with major depression whose blood shows elevated markers of inflammation and who have not fully responded to their current antidepressant, based on the idea that inflammation in the brain may drive treatment-resistant depression in some people. **You may be eligible if...** - You are between 18 and 65 years old - You have a confirmed diagnosis of major depressive disorder (MDD) - Your depression has not fully improved on your current antidepressant, taken at an adequate dose for at least 4 weeks - You are physically healthy - Women of childbearing age must use contraception **You may NOT be eligible if...** - You have bipolar disorder or a psychotic condition - You have a serious physical health condition that could interfere with the study - You plan to change your antidepressant during the study - You have an active inflammatory disease or infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCelecoxib

Oral capsule, 200 mg, twice daily, for 12 weeks

DRUGMinocyclin

Oral capsule, 100 mg, twice daily, for 12 weeks

DRUGPlacebo

Oral capsule, no active substance, twice daily, for 12 weeks


Locations(3)

UPC Duffel

Duffel, Antwerpen, Belgium

UZ Brussel

Brussels, Belgium

Katholiek Universiteit Leuven Campus Kortenberg

Leuven, Belgium

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NCT05644301


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