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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)
EU CTIS ID: 2024-516584-86-00
What this study is testing
The main aim of the study is to assess the efficacy and safety of low-dose acetylsalicylic acid (150 mg / d) as an add-on treatment to standard therapy in the treatment of bipolar disorder.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
You likely can't join if
- Coexisting severe mental disorders (schizophrenia, dementia, addiction, OCD, depression other than in the course of BD);
- Current use of non-pharmacological treatments (psychotherapy and biological treatments, i.e. electroconvulsive therapy, phototherapy, deep brain stimulation, transcranial magnetic stimulation)
- Taking acetylsalicylic acid in a chronic manner due to somatic diseases;
- 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)
- Taking valproates within 7 days prior to the start of the study (due to the risk of significant interactions with ASA)
- Known allergy or hypersensitivity to ASA or other NSAIDs;
See the full eligibility criteria
Who can join
- 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.
What rules you out
- Coexisting severe mental disorders (schizophrenia, dementia, addiction, OCD, depression other than in the course of BD);
- Current use of non-pharmacological treatments (psychotherapy and biological treatments, i.e. electroconvulsive therapy, phototherapy, deep brain stimulation, transcranial magnetic stimulation)
- Taking acetylsalicylic acid in a chronic manner due to somatic diseases;
- 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)
- Taking valproates within 7 days prior to the start of the study (due to the risk of significant interactions with ASA)
- Known allergy or hypersensitivity to ASA or other NSAIDs;
- Pregnant or breastfeeding women;
- 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);
- 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.