Using anti-inflammatory drugs to treat a specific type of depression
Precision Psychiatry: Anti-inflammatory Medication in Immuno-metabolic Depression
This study is testing if adding an anti-inflammatory drug called celecoxib can help people with a specific type of depression that involves inflammation feel better and have more energy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05415397 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of celecoxib, an anti-inflammatory drug, as an add-on treatment for patients diagnosed with ImmunoMetabolic Depression (IMD). IMD is characterized by a combination of inflammatory and metabolic dysregulations along with atypical depressive symptoms. The study aims to personalize treatment by identifying patients with IMD and assessing whether reducing inflammation can alleviate their depressive symptoms and associated fatigue. Participants must be currently undergoing pharmacotherapy or psychotherapy and exhibit specific clinical markers of depression and inflammation.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with Major Depressive Disorder who exhibit symptoms of ImmunoMetabolic Depression and have elevated inflammatory markers.
Not a fit: Patients without the ImmunoMetabolic Depression profile or those who do not meet the inflammatory criteria may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this approach could provide a targeted treatment option for patients suffering from a specific subtype of depression linked to inflammation.
How similar studies have performed: Other studies have shown promising results in treating depression with anti-inflammatory approaches, but this specific focus on ImmunoMetabolic Depression is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * DSM-5 diagnosis of MDD confirmed with clinical interview (MINI-S voor DSM-5 Nederlandse versie 2019) * Currently using pharmacotherapy (e.g., SSRI, SNRI, TCA, TetraCA, MAOI, other antidepressant \[bupropion, vortioxetine, agomelatine\])) and/or psychotherapy. Subjects should be on the current treatment for at least 4 weeks * IDS-SR score ≥26 (moderate to severe depressive symptoms) and a score ≥6 on atypical, energy-related symptoms scale from IDS * CRP \> 1mg/L * A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: 1) is not a woman of child bearing potential (WOCBP); 2) Is a WOCBP and agrees to use, or is already using, a contraceptive method during the intervention period and up to 1 month after the intervention * Signed informed consent Exclusion Criteria: * Contraindications for celecoxib (history of: peptic ulcers, gastrointestinal bleeding, ischemic heart disease, stroke, heart failure, allergic reactions to aspirin/NSAIDs/coxibs; impaired kidney function (creatinine clearance \< 30 ml/min), impaired liver function (ALT \> 2x ULT) * ECT in the past 3 months * Being on other psychotropic drugs * Clinically overt alcohol/drug dependence or other primary psychiatric diagnoses (schizophrenia, schizoaffective, OCD, or bipolar disorder) * Chronic use of anti-inflammatory drugs and corticosteroids * Current use of anticoagulants * Not speaking Dutch
Where this trial is running
Amsterdam
- Department of Psychiatry Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Yuri Milaneschi, PhD — Amsterdam UMC, location VUmc
- Study coordinator: Joël Zwiep, MSc
- Email: j.zwiep@amsterdamumc.nl
- Phone: +31629680809
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.