NCT05415397CompletedPhase 3
Precision psychiatry: Anti-inflammatory medication in Immuno-metabolic depression
Source: EU CTIS (euclinicaltrials.eu) · Last updated 11 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate whether a 12-week celecoxib treatment (400mg/day) added to treatment as usual (TAU, defined as pharmacotherapy and/or psychotherapy) is more effective in reducing depressive symptoms as measured with the Inventory of Depressive Symptomatology (IDS 30-item self-report version) than placebo in patients aged 18-65yr with major depressive disorder and IMD characteristics (atypical, energyrelated symptoms (≥6 on IDS)(Lamers et al. 2020) and circulating CRP>1mg/L) during 12-week follow-up.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 140 (actual)
- First submitted
- 19 Sept 2024
- Start date
- 11 Oct 2024
- Lead sponsor
- Amsterdam UMC Stichting
- Diseases
- Depression
- NCT number
- NCT05415397
- EU CT number
- 2024-513907-15-01
- EudraCT number
- 2021-003850-21
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 140
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Being on other psychotropic drugs
- Chronic use of anti-inflammatory drugs and corticosteroids
Other illness
- Clinically overt alcohol/drug dependence or other primary psychiatric diagnoses (schizophrenia, schizoaffective, OCD, or bipolar disorder)
Lab values
- Contraindications for celecoxib (active peptic ulcers, gastrointestinal bleeding, impaired kidney function (creatinine clearance < 30 ml/min), impaired liver function (ALT > 2x upper limit of normal [ULT]), history of ischemic heart disease or stroke, heart failure, allergic reactions to aspirin/NSAIDs/coxibs, use of anticoagulants
Other
- ECT in the past 3 months
- Not speaking Dutch
Who the study is looking for
- Age 18-65 years
- DSM-5 diagnosis of MDD confirmed with clinical interview (MINI)
- Currently using pharmacotherapy (SSRI, SNRI, TCA, TetraCA, MAOI, other antidepressants [bupropion, vortioxetine, agomelatine]) and/or psychotherapy. Subjects should be on the current treatment for at least 4 weeks
- IDS score ≥26 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: o Is not a woman of child bearing potential (WOCBP) o 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.