Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
NCT05644301

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

Led by Universiteit Antwerpen · Updated on 2024-10-15

240

Participants Needed

3

Research Sites

153 weeks

Total Duration

On this page

Sponsors

U

Universiteit Antwerpen

Lead Sponsor

R

Research Foundation Flanders

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, 18-65 years inclusive.
  • Able and willing to give informed consent and take oral medication.
  • Physically healthy.
  • Diagnosis of Major Depressive Disorder by DSM-5 criteria, confirmed by the Mini International Neuropsychiatric Interview (MINI).
  • Current depressive episode has not improved with current antidepressant treatment at adequate dose or relapse occurred while on antidepressant.
  • Tolerant to current antidepressant with no planned changes during study.
  • Stable on current treatment for at least 4 weeks (6 weeks for fluoxetine) before baseline.
  • If female and of childbearing age, willing to use contraception and take a pregnancy test at baseline.
Not Eligible

You will not qualify if you...

  • Primary diagnosis of bipolar disorder, psychotic spectrum disorder, obsessive-compulsive disorder, eating disorder, post-traumatic stress disorder, or substance use disorder (excluding nicotine and caffeine) within 4 weeks before screening.
  • Use of immunosuppressant or immunostimulant drugs within 21 days before screening.
  • History of peptic ulcer disease or gastrointestinal bleeding.
  • Acute infection or inflammatory bowel disorder.
  • Severe cardiovascular disease, congestive heart failure (NYHA II-IV), ischemic or thrombotic events, or unstable coronary artery including bypass surgery.
  • Liver impairment with specified lab abnormalities or Child-Pugh Score ≥ 10.
  • Renal impairment with creatinine clearance less than 30 mL/min.
  • Use of tetracycline or NSAIDs for more than 14 days in past 2 months or history of sensitivity to these drugs.
  • Chronic severe hypertension with systolic BP over 170 mmHg.
  • Positive tests for hepatitis B, hepatitis C, or HIV.
  • Electroconvulsive therapy within 2 months before screening.
  • Blood donation within 30 days before screening.
  • Pregnancy or breastfeeding.
  • Currently enrolled in another intervention study.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

UPC Duffel

Duffel, Antwerpen, Belgium, 2570

Actively Recruiting

2

UZ Brussel

Brussels, Belgium

Actively Recruiting

3

Katholiek Universiteit Leuven Campus Kortenberg

Leuven, Belgium

Actively Recruiting

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Research Team

J

Jonas Janssens, MD

CONTACT

C

Celine Wessa, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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