The Bipolar Lithium Imaging Scan Study.

Bipolar Disorder Clinical Trial

— BLISS  

Official title:

The Bipolar Lithium Imaging Scan Study: Imaging Lithium in the Brains of Bipolar Disorder (BD) Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06134349
• Other study ID #: NL80214.058.22
• Status: Recruiting
• Start date: March 13, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: March 2024
• Source: Leiden University Medical Center
• Contact: Elvira Boere, MD
• Phone: +31715263785
• Email: E.Boere[@]lumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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"

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years or above

• Confirmed BD diagnosis according to the Composite International Diagnostic Interview

• Start of specialized outpatient treatment for BD OR admission due to first mania

• Starting lithium treatment as part of regular treatment protocol

• Written informed consent

Exclusion Criteria:

• Participants who cannot read, speak or understand Dutch

• Unable to provide informed consent

• Drug or alcohol abuse over a period of six months prior to the experiment

• Patients who meet any exclusion criteria for MRI scanning will be excluded from study participation.

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Device:
• lithium MRSI
lithium magnetic resonance spectroscopy imaging

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of lithium in the brain, using average whole-brain concentration and concentrations in pre-defined regions of interest (ROI).	Concentration of lithium in the brain, using average whole-brain concentration and concentrations in pre-defined regions of interest (ROI).	Baseline
Secondary	Serum lithium levels	Serum lithium levels	Baseline
Secondary	Clinical outcome measures	Retrospective Criteria of Long-term Treatment Response in Research Subjects With Bipolar Disorder scale.; Range 0-10 with 10 indicating lithium response and 0 indicating a lack thereof.	1 year after lithium MRSI