Study population
liver disorder(s, schizophrenia or schizophrenia-spectrum disorder, ischaemic heart disease, ulcer disease or gastrointestinal bleeding, urticaria, hereditary Galactose-intolerance, immune-mediated brain disorder, psychiatric, nasal polyps, hypersensitivity
DISORDER, PERIPHERAL ARTERIAL DISEASE, ISCHAEMIC HEART DISEASE, INFLAMMATORY BOWEL DISEASE, SHEEHAN, ACUTE RHINITIS, URTICARIA, HYPERSENSITIVITY, CONGESTIVE HEART FAILURE, DERMATOLOGICAL DISORDERS, ASTHMA, HYPERTENSION, TYPE 2 DIABETES MELLITUS, CEREBROVASCULAR DISEASE, ANGIONEUROTIC EDEMA
Inclusion criteria are defined as follows: (1) In- and outpatients (men and women) aged between 18 and 65 years with a DSM-V diagnosis of schizophrenia or schizophrenia-spectrum disorder confirmed by the Mini-International Neuropsychiatric Interview (Sheehan et al. Exclusion criteria are as follows: (1) incapacity to give informed consent, (2) suicidality or endangerment of others, (3) coercive treatment or forced placement in a psychiatric hospital at the time of study inclusion, (4) medical history of an immune-mediated brain disorder, (5) chronic use of glucocorticosteroids (temporary use is permitted, if stopped at least 1 month before start of treatment trial), (6) chronic use of non-steroidal anti-inflammatory drugs (temporary use is permitted, if stopped at least 1 month before start of treatment trial; on-demand use is permitted only as topic application), (7) current use of statins or other lipid-lowering drugs, (8) current use of tacrolimus or fluconazole, (9) current use of antihypertensives from the substance class of Angiotensin-converting enzyme (ACE)-inhibitors or Angiotensin II-receptor (AT-II) antagonists or beta-blockers with the exception of propranolol, (10) current use of diuretics, (11) current use of carbamazepine, (12) chronic use of antiplatelet agents (e.g. acetylsalicylic acid (ASS), clopidogrel), marcumar or non-vitamin K antagonist oral anticoagulants (NOACs), (13) known history of treatment-resistant hypertension, or known history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease, or known history of congestive heart failure (NYHA class II–IV) or current use of digoxin, (14) known history of type 2 diabetes mellitus, (15) severe liver disorder(s) (serum albumin < 25 g/l or Child–Pugh score > 10), (16) severe kidney disorder(s) (estimated creatinine clearance < 30 ml/min), (17) known history of systemic dermatological disorders, (18) known history of ulcer disease or gastrointestinal bleeding, (19) known history of inflammatory bowel disease, (20) pregnancy or breastfeeding, (21) known history of asthma, acute rhinitis, nasal polyps, angioneurotic edema, urticaria or other allergictype reactions after taking ASS or other non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 (cyclooxygenase-2)-inhibitors, (22) known hypersensitivity to sulphonamides, known history of hereditary Galactose-intolerance, complete Lactase-deficiency or Glucose-Galactose-malabsorption disorder and (23) intolerance to one of the study drugs. (24) For male participants: pregnancy or breastfeeding of the partner will lead to exclusion. (25) Concurrent enrolment in another clinical trial where the participant is receiving an IMP or participation in another clinical trial with IMP during the last 30 days before inclusion or 7 half-lives of previously used IMP, whichever is longer, is also excluded.