Bipolar DisorderNCT06581822
Biomarkers for Pharmacoresponse in Bipolar Disorder - Coagulation
An observational study of Bipolar Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bipolar Disorder
- How many people
- 68 participants
- Where
- 1 siteSweden
- Study dates
- 24 Feb 2017to Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Bipolar Disorder
- Medical subject headings
- Bipolar Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Extracellular vesicles
Counts of plasma extracellular vesicles originating from blood platelets, leukocytes and vascular endothelial cells.
Measured: From enrollment to end of examination at 2 years
Hemostatic potential
Overall hemostatic potential (OHP), coagulation potential (OCP) fibrinolytic potential (OFP) i citrate plasma.
Measured: From enrollment to end of examination at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start24 Feb 2017
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catharina Lavebratt Holmquist, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581822
- Sponsor's protocol ID
- 2023-04886-02
- Other IDs
- 2023
- Status last verified
- Feb 2025
- First submitted
- 29 May 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planning to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers for Pharmacoresponse in Bipolar Disorder - Coagulation
- ClinicalTrials.gov ID
- NCT06581822
- Acronym / sponsor ID
- 2023-04886-02
- Conditions
- Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No. Not planning to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extracellular vesicles (time frame: From enrollment to end of examination at 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.