Biomarkers for Pharmacoresponse in Bipolar Disorder - Coagulation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06581822

Enrollment

Registered

2024-09-03

Start date

2017-02-24

Completion date

2025-04-30

Last updated

2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* Inability to give informed consent

Design outcomes

Primary

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Plasma proteins of coagulation- or fibrinolysis-related processes	From enrollment to end of examination at 2 years	Concentration in plasma of proteins involved in coagulation or fibrinolysis such as von Willebrand factor

Countries

Sweden

Outcome results