The Bipolar Lithium Imaging Scan Study.
Recruiting · NCT06134349 · Observational (researchers observe without assigning treatment) · Lead sponsor: Leiden University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- age 18 years or above,
- a clinical diagnosis of bipolar disorder type I or type II ,
- 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
- provided written informed consent.
Exclusion criteria
- insufficient comprehension of the Dutch language,
- unable to provide informed consent,
- drug or alcohol abuse over a period of two weeks prior to study participation, and
- meeting any exclusion criterium for MR imaging.
Where it is running
1 location listed.
- Leiden University Medical Center - Leiden, South Holland, Netherlands