Status:
RECRUITING
Treating Immuno-metabolic Depression With Anti-inflammatory Drugs
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
Netherlands Brain Foundation
Conditions:
Depressive Disorder, Major
Inflammation
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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. Howeve...
Detailed Description
Rationale: Depression is a major driver of disability and related health-care costs. Available treatment options are far from optimal, with only \~60% response. Developing effective treatments require...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05415397
Start Date
September 28 2022
End Date
July 1 2026
Last Update
October 6 2025
Active Locations (1)
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1
Department of Psychiatry Amsterdam UMC
Amsterdam, Netherlands, 1081 HJ