Investigating how brain lithium levels affect treatment response in bipolar disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Leiden University Medical Center
  Leiden, South Holland, Netherlands Recruiting

Study contacts

• Study coordinator: E Boere
• Email: bliss@lumc.nl
• Phone: +31(0)715263785

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.