Biomarkers for Pharmacoresponse in Bipolar Disorder - Coagulation

NCT ID: NCT06581822

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-24

Study Completion Date

2025-04-30

Brief Summary

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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

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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 MÃ¥nsson, KI).
* using a prospective cohort design, following the patients over time.

Conditions

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Bipolar Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Catharina Lavebratt Holmquist

Research group leader

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Karolinska Institutet

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2023-04886-02

Identifier Type: -

Identifier Source: org_study_id

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