RecruitingPhase 3NCT05415397

Treating Immuno-metabolic Depression With Anti-inflammatory Drugs

Precision Psychiatry: Anti-inflammatory Medication in Immuno-metabolic Depression


Sponsor

Amsterdam UMC, location VUmc

Enrollment

140 participants

Start Date

Sep 28, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether anti-inflammatory medications can help people with depression who also show signs of immune system overactivation and metabolic changes. Some people with depression don't fully respond to standard antidepressants, and researchers think inflammation may be a key reason why. **You may be eligible if...** - You have been diagnosed with major depressive disorder (MDD) - You are currently taking antidepressant medication and/or receiving psychotherapy - Your depression has not fully responded to treatment - You have certain blood markers suggesting inflammation (elevated CRP, lipids, glucose, or waist circumference) **You may NOT be eligible if...** - You have bipolar disorder, psychosis, or a personality disorder - You are currently in a manic or hypomanic episode - You have active suicidal thoughts or have recently attempted suicide - You use anti-inflammatory drugs, corticosteroids, or omega-3 supplements regularly - You are pregnant or breastfeeding - You have significant physical health conditions (liver or kidney disease, diabetes requiring medication, autoimmune conditions) 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 400mg

Celecoxib add-on (400mg daily) add-on to treatment as usual (standard antidepressant treatment)

DRUGPlacebo

Placebo add-on to treatment as usual (standard antidepressant treatment)


Locations(1)

Department of Psychiatry Amsterdam UMC

Amsterdam, Netherlands

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NCT05415397


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