depression Major depressive disorder
Conditions
Interventions
celecoxib add-on (400 mg/d) vs placebo
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: * 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
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * 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 2x upper limit of normal [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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome parameter is mean severity of depression symptoms, as measured with the 30-item Inventory of Depressive Symptomatology - self-report during follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters include amongst others, response on the IDS, remission, anxiety, fatigue, food craving, sleep and adverse side events | — |
Countries
Netherlands
Outcome results
None listed