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Kortenberg","Leuven",{"type":70,"coordinates":99},[100,101],4.70093,50.87959,{"lat":101,"lon":100},[104,106],{"name":105,"role":54,"phone":11,"phoneExt":11,"email":11},"Elfi Vergaelen, MD PhD",{"name":107,"role":81,"phone":11,"phoneExt":11,"email":11},"Emma Saillart",{"type":50,"investigatorFullName":77,"investigatorTitle":109,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Professor Doctor",[111,113,115,117],{"name":112,"class":6},"Research Foundation Flanders",{"name":114,"class":6},"KU Leuven",{"name":116,"class":6},"Vrije Universiteit Brussel",{"name":118,"class":6},"Amsterdam UMC, location VUmc","100488760","phase-3-inflammation-based-stratification-for-immune-targeted-augmentation-in-major-depressive-disorder-100488760",false,"NCT05644301","INflammation-based Stratification for Immune-Targeted Augmentation in Major Depressive Disorder","INflammation-based Stratification for Immune-Targeted Augmentation in Major Depressive","INSTA-MD","Inclusion Criteria:\n\n* 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Relapse while taking an antidepressant is also considered a treatment failure.\n* Tolerant to the current antidepressant and having no planned changes in their current therapy for the duration of the study.\n* Stable on current treatment for a minimum of 4 weeks (6 weeks for fluoxetine) prior to baseline.\n* If female and of childbearing age, willing to use adequate contraceptive precautions and willing to take a pregnancy test at baseline.\n\nExclusion Criteria:\n\n* Primary diagnosis of a bipolar disorder, psychotic spectrum disorder, obsessive-compulsive disorder, eating disorder, post-traumatic stress disorder, or alcohol and\u002For substance use disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (\\\u003C 4 weeks before screening, excl. nicotine and caffeine).\n* Use of immunosuppressant or immunostimulant drugs within 21 days of screening (e.g., glucocorticoid treatment, methotrexate, etc.).\n* History of peptic ulcer disease or gastrointestinal (GI) bleeding.\n* Having an acute infection or inflammatory bowel disorder.\n* Current severe cardiovascular disease, congestive heart failure (NYHA-class II-IV), ischemic or thrombotic events or unstable coronary artery (incl. coronary artery bypass graft (CABG) surgery),\n* Liver impairment (alanine aminotransferase \\> 2x upper limit, serum albumin \\\u003C 25 g\u002Fl or Child-Pugh Score ≥ 10)\n* Renal impairment (creatinine clearance \\\u003C 30 mL\u002Fmin).\n* Having received \\>14 days of tetracycline or non-steroidal anti-inflammatory medication within the previous 2 months, or having a history of sensitivity or intolerance to these classes of drugs.\n* Chronic severe hypertension (systolic BP \\> 170 mmHg).\n* Serology positive for hepatitis-B surface antigen, hepatitis-C antibodies or HIV antibodies.\n* Received electroconvulsive therapy \\\u003C 2 months prior to screening.\n* Blood donation in 30 days prior to screening.\n* Pregnancy or breastfeeding.\n* Currently enrolled in an intervention study.","ALL","18 Years","65 Years",{"count":131,"type":132},240,"ESTIMATED","INTERVENTIONAL",[135],"PHASE3","This is a randomised, double-blind, placebo-controlled clinical trial in which patients with major depressive disorder will receive augmentation through minocycline (MCO), celecoxib (CXB) or placebo.",[138,139],"Major Depressive Disorder","Inflammation",[141,35,39,139,142],"Immunopsychiatry","Randomised Controlled Clinical Trial","2024-10-09",{"date":145,"type":146},"2024-10-15","ACTUAL",{"date":148,"type":146},"2023-09-21",{"date":150,"type":132},"2026-09",{"name":5,"class":6},3]