BLISS: The Bipolar Lithium Imaging Scan Study.

Sponsor

Leiden University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06134349

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Device: lithium MRSI

Detailed 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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 1, 2027

Anticipated Study Completion Date :

Jan 1, 2027

Outcome Measures

Primary Outcome Measures

Concentration of lithium in the brain, using average whole-brain concentration and concentrations in pre-defined regions of interest (ROI). [Baseline]
Concentration of lithium in the brain, using average whole-brain concentration and concentrations in pre-defined regions of interest (ROI).

Secondary Outcome Measures

Serum lithium levels [Baseline]
Serum lithium levels
Clinical outcome measures [1 year after lithium MRSI]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leiden University Medical Center	Leiden	Zuid Holland	Netherlands	2333 ZA

Sponsors and Collaborators

Leiden University Medical Center

Investigators

Principal Investigator: Max de Leeuw, MD, PhD, Leiden University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elvira Boere, MD, Leiden University Medical Center

ClinicalTrials.gov Identifier:

NCT06134349

Other Study ID Numbers:

NL80214.058.22

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Elvira Boere, MD, Leiden University Medical Center

bipolar disorder

lithium

magnetic resonance spectroscopy imaging

neuroimaging

Additional relevant MeSH terms:

Bipolar Disorder

Lithium Carbonate

Study Results

No Results Posted as of Nov 18, 2023