Study to evaluate the efficacy and safety of low-dose aspirin as an add-on to standard therapy in patients with bipolar disorder (ASPIRIN BD)

Prior treatment

• Current use of non-pharmacological treatments (psychotherapy and biological treatments, i.e. electroconvulsive therapy, phototherapy, deep brain stimulation, transcranial magnetic stimulation)
• Taking valproates within 7 days prior to the start of the study (due to the risk of significant interactions with ASA)
• A patient who received any investigational drug not authorized in the country where the clinical trial is conducted within 30 days immediately before the start of the trial.

Other illness

• Coexisting severe mental disorders (schizophrenia, dementia, addiction, OCD, depression other than in the course of BD);
• Taking acetylsalicylic acid in a chronic manner due to somatic diseases;
• Known allergy or hypersensitivity to ASA or other NSAIDs;

Lab values

• Regular use of steroid or non-steroidal anti-inflammatory drugs (occasional use of NSAIDs is allowed), methotrexate, digoxin, acetazolamide, antidiabetic drugs - insulin and drugs from the sulfonylurea group, anticoagulants (coumarin derivatives, heparin, oral anticoagulants from the group of non-vitamin K antagonists rivaroxaban, apixaban, dabigatran), thrombolytic or platelet aggregation drugs (ticlopidine, clopidogrel)
• Asthma, which, in the investigator's opinion, would increase the risk of an asthma attack; history of serious somatic disease (e.g. significant valvular heart disease, heart failure, hypertrophic cardiomyopathy, severe or worsening cardiomyopathy, clinically significant ECG abnormalities (defined as PR> 240msec, QRS complex> 110msec, QTcF> 500, ST segment depression) > 2 mm, ST-segment elevation> 1 mm, severe obstructive pulmonary disease, untreated thyroid disease, diagnosed HIV or hepatitis A, B or C, myocardial infarction in the last 6 months, insulin-dependent diabetes mellitus, gout). includes any somatic uncontrolled (in the last 3 months prior to study entry) disease states; a positive history of gastrointestinal, liver or kidney disease, or any other abnormal condition that impairs the function of these organs and may result in the possibility of altered absorption, excessive accumulation, or metabolic disorders or excretion of study medication. such as: history of major gastrointestinal surgery (e.g. gastrectomy, gastroenterostomy, bowel resection etc.) or a current diagnosis of an active gastrointestinal disease, gastric or duodenal ulceration, chronic gastrointestinal disease (e.g. ulcerative colitis, ileitis or gastrointestinal bleeding); liver damage, ie values ≥ 3 times the upper limit of normal for at least two of the following - ALT, ASP, LDH, alkaline phosphatase, or bilirubin; impaired renal function as indicated by clinically significant abnormalities for blood urea nitrogen (≥ 30 mg / dL) and creatinine (≥ 2 mg / dL), as well as by the presence of abnormal urine components (eg Albuminuria);
• Patients with menorrhagia. Objectively heavy menstrual bleeding is defined as prolonged (>7 days) excessive blood loss of more than 80 mL per menstrual cycle. Clinical signs predictive of heavy menstrual bleeding include clots >2.5 cm in size, low serum ferritin levels, seepage and the need to change a sanitary pad or tampon more often than every hour, as well as menstrual bleeding.

Other

• Pregnant or breastfeeding women;

• Diagnosis of bipolar disorder (criterion verified by the qualifying physician on the basis of clinical history and criteria included in the classification of diseases ICD-10, code F31);
• Current episode of depression (ICD-10 codes F31.3-F31.5);
• Age 18-60 years; women and men;
• Current treatment with at least one mood stabilizer recommended in bipolar disorder, except for valproates;
• The patient is able to give informed consent to participate in the study;
• The patient's body mass index is within the appropriate range (BMI> 18 and <40 kg / m2, where BMI = body weight (kg) / [height (m)] 2).
• In women of childbearing age, a negative serum pregnancy test at screening and agreement to use highly effective contraceptive methods during the study (Women of childbearing potential (WOCBP) is defined as any woman or adolescent who has begun menstruation. A postmenopausal woman is defined as a woman who is over the age of 45 and has not had a menstrual period for at least 12 months). *Due to enzyme induction, carbamazepine may cause hormonal contraception to be ineffective, so patients of childbearing age taking carbamazepine as standard therapy should be advised to use other effective methods of contraception.