INflammation-based Stratification for Immune-Targeted Augmentation in Major Depressive Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversiteit Antwerpen
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
Primary diagnosis of a bipolar disorder, psychotic spectrum disorder, obsessive-compulsive disorder, eating disorder, post-traumatic stress disorder, or alcohol and/or substance use disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (< 4 weeks before screening, excl. nicotine and caffeine).
Use of immunosuppressant or immunostimulant drugs within 21 days of screening (e.g., glucocorticoid treatment, methotrexate, etc.).
History of peptic ulcer disease or gastrointestinal (GI) bleeding.
Having an acute infection or inflammatory bowel disorder.
Trial design
Treatments tested in this trial
- Celecoxib
- Minocyclin
- Placebo
Treatment groups
240 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Universiteit Antwerpen
Lead sponsor
Research Foundation Flanders
Collaborator
KU Leuven
Collaborator
Vrije Universiteit Brussel
Collaborator
Amsterdam UMC, location VUmc
Collaborator
Source ClinicalTrials.gov