Pure Global

The Bipolar Lithium Imaging Scan Study. - Trial NCT06134349

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.

Free Database
Powered by Pure Global AI
840K+ Trials
Device Trial
NCT06134349
Not yet recruiting
Device Trial
device
Trial Details
ClinicalTrials.gov โ€ข NCT06134349
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

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

Study Focus

Bipolar Disorder

lithium MRSI

Observational

device

Sponsor & Location

Leiden University Medical Center

Leiden, Netherlands

Timeline & Enrollment

N/A

Jan 01, 2024

Jan 01, 2027

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 disorder
Bipolar affective disorder, unspecified
Other bipolar affective disorders
Bipolar affective disorder, currently in remission
Bipolar affective disorder, current episode mixed

Data Source

ClinicalTrials.gov

NCT06134349

Device Trial