Study of Minocycline and Celecoxib as Added Treatments for Immune-Related Major Depressive Disorder Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial

What this Trial Is About

Researchers are investigating the use of two anti-inflammatory drugs, minocycline and celecoxib, as add-on treatments for a subtype of major depressive disorder linked to immune system activity. This immunological subtype affects about 30% of people with depression and is associated with more severe symptoms, lower quality of life, and resistance to standard antidepressants. The study aims to identify which patients benefit most from these supplements by stratifying participants based on their inflammation levels at the start. Participants will be randomly assigned to receive either minocycline 100 mg twice daily, celecoxib 200 mg twice daily, or a placebo along with their usual antidepressant treatment for 12 weeks. The study uses a double-blind design, meaning neither the participants nor the researchers know who is receiving which treatment. Groups are further divided based on their baseline inflammation marker, high sensitive C-reactive protein hs-CRP, to compare responses between low and high inflammation levels. During the study, participants will have their depression symptoms assessed using standard rating scales at the beginning and after 12 weeks of treatment. Additional measures include sleep quality, anxiety, psychomotor changes, therapy compliance, side effects, and metabolic markers. The trial lasts 12 weeks, focusing on changes in depression severity and remission rates, with careful monitoring to ensure participant safety throughout the study period.

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