NCT06134349 The Bipolar Lithium Imaging Scan Study.
| NCT ID | NCT06134349 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leiden University Medical Center |
| Condition | Bipolar Disorder I or II |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-03-13 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-03-13 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main goal of this study is to determine if brain lithium-concentrations predict clinical lithium treatment-response. Secondary, to study correlations between intracerebral distribution-patterns of lithium with clinical treatment outcome. Brain lithium concentrations will be measured using ultra-high field (7 Tesla) lithium magnetic resonance (MR) imaging, which has recently been introduced. Determining lithium-concentrations in the brain has been difficult so far due to lithium's relatively low concentration (compared to protons, which are targeted in conventional MRI). 7T lithium MR imaging has the potential to produce much more detailed MR images compared with previous studies, for the first time. The BLISS study is expected to yield new insights, helping to better understand why clinical lithium response varies between individuals.
Eligibility Criteria
Inclusion Criteria: 1. age 18 years or above, 2. a clinical diagnosis of bipolar disorder type I or type II , 3. having reached stable therapeutic serum lithium concentrations (reference values 0.6-1.0 mM in age to 65 years; 0.4-0.8 in age 65 years and above) within four weeks prior to study participation, and 4. provided written informed consent. Exclusion Criteria: 1. insufficient comprehension of the Dutch language, 2. unable to provide informed consent, 3. drug or alcohol abuse over a period of two weeks prior to study participation, and 4. meeting any exclusion criterium for MR imaging.
Contact & Investigator
E Boere, MD
STUDY CHAIR
Leiden University Medical Center
Frequently Asked Questions
Who can join the NCT06134349 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bipolar Disorder I or II. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06134349 currently recruiting?
Yes, NCT06134349 is actively recruiting participants. Contact the research team at bliss@lumc.nl for enrollment information.
Where is the NCT06134349 trial being conducted?
This trial is being conducted at Leiden, Netherlands.
Who is sponsoring the NCT06134349 clinical trial?
NCT06134349 is sponsored by Leiden University Medical Center. The principal investigator is E Boere, MD at Leiden University Medical Center. The trial plans to enroll 80 participants.
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