Biomarkers for Pharmacoresponse in Bipolar Disorder - Coagulation

NCT06581822 | Active Not Recruiting

• 1 other identifier: 2023-04886-02
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (2)

• Extracellular vesicles

  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

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

  From enrollment to end of examination at 2 years

Other Outcomes (1)

• Plasma proteins of coagulation- or fibrinolysis-related processes

  From enrollment to end of examination at 2 years

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Inability to give informed consent

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, 17176, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research group leader

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: September 3, 2024
• Study Start: February 24, 2017
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)