Pure Global AI
NCT06134349Not yet recruiting

The Bipolar Lithium Imaging Scan Study.

The Bipolar Lithium Imaging Scan Study: Imaging Lithium in the Brains of Bipolar Disorder (BD) Patients.
Leiden University Medical CenterClinicalTrials.govdeviceDevice trial
Verified
Study focus
Disease/Condition
Bipolar Disorder
Drug/Device/Intervention
lithium MRSI
Study type
Observational
Intervention type
device
Sponsor & location
Primary sponsor
Leiden University Medical Center
Location
Leiden, Netherlands
Timeline & enrollment
Phase
N/A
Start date
Jan 01, 2024
End date
Jan 01, 2027
Enrollment
80 participants
Primary outcome

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

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.

ICD-10 classifications
Bipolar affective disorderBipolar affective disorder, unspecifiedOther bipolar affective disordersBipolar affective disorder, currently in remissionBipolar affective disorder, current episode mixed
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06134349
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06134349 through Pure Global AI's free database. This phase not specified trial is sponsored by Leiden University Medical Center and is currently Not yet recruiting. The study focuses on Bipolar Disorder. Target enrollment is 80 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.