NCT06134349Recruiting
The Bipolar Lithium Imaging Scan Study.
The Bipolar Lithium Imaging Scan Study: Imaging Lithium in the Brains of Subjects with Bipolar Disorder
Source: ClinicalTrials.gov · Last updated 13 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The main goal of this study is to determine if brain lithium-concentrations predict clinical lithium treatment-response. Secondary, to study correlations between intracerebral distribution-patterns of lithium with clinical treatment outcome. Brain lithium concentrations will be measured using ultra-high field (7 Tesla) lithium magnetic resonance (MR) imaging, which has recently been introduced. Determining lithium-concentrations in the brain has been difficult so far due to lithium's relatively low concentration (compared to protons, which are targeted in conventional MRI). 7T lithium MR imaging has the potential to produce much more detailed MR images compared with previous studies, for the first time. The BLISS study is expected to yield new insights, helping to better understand why clinical lithium response varies between individuals.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 8 Nov 2023
- Start date
- 13 Mar 2024
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- Leiden University Medical Center
- Diseases
- Bipolar disorder
- NCT number
- NCT06134349
What you commit to
- Study type: Observational
- Planned participants: 80
- From 13 Mar 2024 to the primary completion date, 1 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- drug or alcohol abuse over a period of two weeks prior to study participation, and
Other
- insufficient comprehension of the Dutch language,
- unable to provide informed consent,
- meeting any exclusion criterium for MR imaging.
Who the study is looking for
- age 18 years or above,
- a clinical diagnosis of bipolar disorder type I or type II ,
- having reached stable therapeutic serum lithium concentrations (reference values 0.6-1.0 mM in age to 65 years; 0.4-0.8 in age 65 years and above) within four weeks prior to study participation, and
- provided written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Leiden University Medical Center Coordinator of this site? Confirm its status | Leiden | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.