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Active, not recruitingNCT06581822Updated Feb 19, 2025

Biomarkers for Pharmacoresponse in Bipolar Disorder - Coagulation

An observational study in Bipolar Disorder, sponsored by Karolinska Institutet. Active, not recruiting at 1 site in Sweden. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-02-19.

Sponsored by Karolinska Institutet · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
68
Ages
18 Years to 100 Years
Sex
All
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Study 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.

Read the 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.
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Conditions studied

  • Bipolar Disorder

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In context

Bipolar Disorder

1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.

This study's enrollment of 68 is below the median of 160 across 329 observational studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Inability to give informed consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
68 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Extracellular vesicles

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

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

  2. Hemostatic potential

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

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

Other outcomes

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

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

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

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Study locations

1 site
  • Karolinska Institutet
    Stockholm, 17176, Sweden
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References and documents

Individual participant data

Plan to share: No — Not planning to share IPD

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06581822
Lead sponsor
Karolinska Institutet
Responsible party
Catharina Lavebratt Holmquist (Research group leader, Karolinska Institutet) — Principal investigator
First posted
Sep 3, 2024
Start date
Feb 24, 2017
Primary completion
Apr 2025 (estimated)
Completion
Apr 2025 (estimated)
Last update
Feb 19, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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