Investigating how brain lithium levels affect treatment response in bipolar disorder
The Bipolar Lithium Imaging Scan Study: Imaging Lithium in the Brains of Subjects with Bipolar Disorder
This study is testing if measuring lithium levels in the brain can help predict how well adults with bipolar disorder will respond to lithium treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden, South Holland) |
| Trial ID | NCT06134349 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine if brain lithium concentrations can predict how well patients with bipolar disorder respond to lithium treatment. Using ultra-high field (7 Tesla) lithium magnetic resonance imaging, the study will measure lithium levels in the brain of 80 adults who are starting lithium therapy. The primary outcome will be assessed through a validated questionnaire at one-year follow-up, with a focus on correlating brain lithium concentrations with clinical treatment outcomes. This innovative approach seeks to enhance understanding of the variability in treatment responses among individuals.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of bipolar disorder type I or II who have achieved stable therapeutic serum lithium concentrations.
Not a fit: Patients who do not meet the inclusion criteria or have conditions that prevent MR imaging will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective lithium treatment strategies for patients with bipolar disorder.
How similar studies have performed: While the use of ultra-high field imaging is relatively novel, previous studies have indicated potential for imaging techniques to improve understanding of treatment responses in bipolar disorder.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age 18 years or above, 2. a clinical diagnosis of bipolar disorder type I or type II , 3. 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 4. provided written informed consent. Exclusion Criteria: 1. insufficient comprehension of the Dutch language, 2. unable to provide informed consent, 3. drug or alcohol abuse over a period of two weeks prior to study participation, and 4. meeting any exclusion criterium for MR imaging.
Where this trial is running
Leiden, South Holland
- Leiden University Medical Center — Leiden, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: E Boere
- Email: bliss@lumc.nl
- Phone: +31(0)715263785
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.