Biomarkers for Pharmacoresponse in Bipolar Disorder - Coagulation
- Conditions
- Bipolar Disorder
- Registration Number
- NCT06581822
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
Previous studies indicate an association between severe psychiatric disorders, such as bipolar disorder, and increased risk of venous thromboembolism. However, to which extent this association is influenced by lithium treatment is currently unknown. In this prospective cohort study, the investigators aim to investigate the effect of bipolar disorder and lithium treatment on coagulation and the counterpart fibrinolysis.
- Detailed Description
The investigators will analyse differences in coagulation
* using a case-control design where cases are bipolar patients not yet treated with lithium, and controls are healthy volunteers (Swedish ethical review authority Dnr 2023-05799-02, PI Kristoffer Månsson, KI).
* using a prospective cohort design, following the patients over time.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 68
- Patients diagnosed with bipolar disorder but not yet treated with lithium, where there is a decision by the patient and the responsible doctor to start lithium treatment.
- Inability to give informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Extracellular vesicles From enrollment to end of examination at 2 years Counts of plasma extracellular vesicles originating from blood platelets, leukocytes and vascular endothelial cells.
Hemostatic potential From enrollment to end of examination at 2 years Overall hemostatic potential (OHP), coagulation potential (OCP) fibrinolytic potential (OFP) i citrate plasma.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Karolinska Institutet
🇸🇪Stockholm, Sweden