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Clinical Trials in the Netherlands / NCT06134349
Recruiting Observational

The Bipolar Lithium Imaging Scan Study.

NCT06134349 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Leiden University Medical Center
Phase
Observational
Started
2024-03-13
Last updated
2024-12-13

Condition(s) studied

Bipolar Disorder I or II

Investigational drug(s) / intervention(s)

Lithium MR imaging

Lithium MR imaging: After obtaining written informed consent and within four weeks of reaching a stable therapeutic serum lithium concentration, lithium MR imaging will be performed using a 7 Tesla MR system (Achieva, Philips Medical Systems, Eindhoven, The Netherlands) with a dual-tuned 7Li/1H volume head coil (RAPID Biomedical GmbH, Rimpar, Germany). Various approaches, including whole-brain, voxel-wise, parcellation, mean, and regions of interest, will be applied to measure lithium concentrations.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Clinical lithium response — At 12-month follow-up.
    Clinical lithium response will be assessed using a validated questionnaire.

Trial sites (1)

FacilityCityRegionStatus
Leiden University Medical Center Leiden South Holland Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06134349 on ClinicalTrials.gov ↗ ← All trials in the Netherlands