Biomarkers for Pharmacoresponse in Bipolar Disorder - Coagulation

February 17, 2025 updated by: Catharina Lavebratt Holmquist, Karolinska Institutet
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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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. Patients are recruited in specialized care.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to end of examination at 2 years
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.
From enrollment to end of examination at 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to end of examination at 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2017

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

May 29, 2024

First Submitted That Met QC Criteria

August 29, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-04886-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not planning to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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