The Bipolar Lithium Imaging Scan Study (BLISS): protocol for a 7T lithium-7 magnetic resonance study in bipolar disorder.
Elvira Boere, Nic J A van der Wee, Albert M van Hemert...
https://pubmed.ncbi.nlm.nih.gov/40160802Actively Recruiting
Age: 18Years +
All Genders
ID06134349
The Bipolar Lithium Imaging Scan Study: Imaging Lithium in the Brains of Subjects with Bipolar Disorder
Led by Leiden University Medical Center · Updated on 2024-12-13
80
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
P
PsyQ
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether lithium levels in the brain can predict how well people with bipolar disorder respond to lithium treatment. This observational study focuses on adults with bipolar disorder type I or II who have recently started lithium as part of their regular care. The study aims to better understand why responses to lithium vary among individuals by using a new imaging technique. Participants will undergo ultra-high-field lithium magnetic resonance imaging (7 Tesla) once they reach stable therapeutic lithium levels in their blood. This advanced imaging method allows detailed measurement of lithium concentrations in various brain regions. The study will follow participants for one year, during which their clinical response to lithium will be evaluated using a validated questionnaire. During the study, brain scans will be done within four weeks after achieving stable lithium blood levels. Researchers will collect data on lithium distribution in the brain and link this to treatment outcomes at 12 months. Participants will provide written consent and be monitored for clinical response. The primary measure is lithium response at one year, with blood lithium levels also recorded at baseline. The study lasts at least 12 months for each participant, allowing detailed observation of treatment effects.
CONDITIONS
Brief Title
The Bipolar Lithium Imaging Scan Study.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical diagnosis of bipolar disorder type I or type II
- Reached stable therapeutic serum lithium concentrations within four weeks before participation
- Provided written informed consent
You will not qualify if you...
- Insufficient comprehension of the Dutch language
- Unable to provide informed consent
- Drug or alcohol abuse within two weeks prior to participation
- Any exclusion criteria for MR imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Imaging Evaluation
Duration - Within 4 weeks after stable lithium levels are reached
Participants undergo ultra-high-field lithium magnetic resonance imaging within four weeks of reaching stable therapeutic serum lithium concentrations to measure lithium concentrations in the brain.
1 visit (in-person)
Long-term Monitoring
Duration - 12 months
Participants are followed for 12 months to assess clinical response to lithium treatment using validated questionnaires.
1 follow-up visit at 12 months
Trial Site Locations
Total: 1 location
1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZA
Actively Recruiting
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Research Team
E
E Boere
O
Onderzoekscentrum Psychiatrie, OZC
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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