Treating Immuno-metabolic Depression With Anti-inflammatory Drugs
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
As the role of (neuro)inflammation in depression is emerging, augmentation of antidepressant
treatments with anti-inflammatory drugs such as celecoxib has shown encouraging preliminary
results. However, inflammation is not present in all depressed patients. Depression is
heterogeneous: patients express diverse and sometimes opposing symptoms and biological
profiles. The investigators of the present trial recently introduced the concept of
ImmunoMetabolic Depression (IMD), characterized by the clustering of inflammatory/metabolic
dysregulations and atypical, energy-related symptoms (hyperphagia, weight gain, hypersomnia,
fatigue and leaden paralysis), and present in approximately 30% of cases. Converging evidence
suggests that in this subgroup of depression cases, inflammation may exert a crucial
pathobiological mechanism, representing therefore an actionable therapeutic target. In this
trial IMD will be applied as a tool to personalize treatment, by matching depressed subjects
with IMD with a targeted anti-inflammatory add-on treatment.
In this study, 140 persons with IMD will be selected. In this specific group of patients, the
investigators will test whether celecoxib add-on (400 mg/d) is more effective than placebo in
the treatment of depression through a 12-week double-blind, randomized (1:1),
placebo-controlled trial. By selecting specifically depressed patients with IMD, the proposed
treatment selectively targets key inflammatory pathophysiological pathways to enhance
clinical outcome for depression. This personalized approach is expected to lead to large
health gains for a sizable proportion of patients. The main hypothesis is that the group of
patients with IMD receiving TAU + celecoxib, as compared to the TAU + placebo, will show a
better symptom course over the 12-week follow-up.