The Bipolar Lithium Imaging Scan Study.

Status Recruiting

Clinical Trial Summary

The primary goal of this observational study is to explore to which extent lithium concentrations in the brains in BD subjects correlate with clinical treatment response. Secondary, to determine correlations of brain lithium concentrations with serum lithium levels. Participants will undergo lithium magnetic resonance spectroscopy imaging (MRSI) within two weeks of reaching adequate serum lithium level. A blood sample will be drawn to determine lithium serum level and after one year a validated questionnaire will be used to assess clinical lithium response. Participants start with lithium treatment as part of their regular treatment.

Clinical Trial Description

Rationale: Lithium treatment is considered the first option in pharmacological treatment of bipolar disorder (BD). Individual responses however vary greatly, which undermines rapid stabilization in many BD-patients. Novel developments in neuro-imaging enable us to determine the concentration and distribution patterns of lithium in the brains of BD-patients. These highly specialized neuro-imaging data are not yet available and is expected to provide groundbreaking information on how lithium exerts its therapeutic effects, thereby potentially increasing the current moderate success rates of lithium treatment. Objectives: Primary: to establish the correlation of neuroimaging data from 7T lithium-MRSI in BD patients with longitudinal clinical lithium treatment outcome measures. Secondary: to establish the correlation of these neuroimaging data to serum lithium levels. Study design: 7 Tesla (7T) MRSI in BD patients starting lithium treatment as part of their regular treatment. Patients are recruited from an ongoing study. Study population: 80 BD patients. Intervention: Subjects will undergo 7T lithium MRSI. Also a blood sample will be collected to determine serum lithium levels. Main study parameters/endpoints: Concentration of lithium in the brain, using average whole-brain concentration and concentrations in pre-defined regions of interest (ROI). Secondary: serum lithium levels and scores on a validated rating scale to assess lithium treatment response "Retrospective Criteria of Long-Term Treatment Response in Research Subjects with Bipolar Disorder" ;

Study Design

Related Conditions & MeSH terms

Bipolar Disorder

Clinical Trial Details

NCT number	NCT06134349
Study type	Observational [Patient Registry]
Source	Leiden University Medical Center
Contact	Elvira Boere, MD
Phone	+31715263785
Email	E.Boere@lumc.nl
Status	Recruiting
Phase
Start date	March 13, 2024
Completion date	January 1, 2027

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Bipolar Lithium Imaging Scan Study. — BLISS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms