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Active, Not Recruiting

NCT Number: NCT06581822

Biomarkers for Pharmacoresponse in Bipolar Disorder - Coagulation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska Institutet

Stockholm, 17176, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Extracellular vesicles

    Time frame: From enrollment to end of examination at 2 years

    Counts of plasma extracellular vesicles originating from blood platelets, leukocytes and vascular endothelial cells.

  2. Hemostatic potential

    Time frame: From enrollment to end of examination at 2 years

    Overall hemostatic potential (OHP), coagulation potential (OCP) fibrinolytic potential (OFP) i citrate plasma.

Other outcomes

  1. Plasma proteins of coagulation- or fibrinolysis-related processes

    Time frame: From enrollment to end of examination at 2 years

    Concentration in plasma of proteins involved in coagulation or fibrinolysis such as von Willebrand factor

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Sep 3, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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