Bipolar Disorder (BPD) Clinical Trials

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The Bipolar Lithium Imaging Scan Study: Imaging Lithium in the Brains of Subjects with Bipolar Disorder

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Leiden University Medical Center
RECRUITING
Leiden
Contact Information
Primary
E Boere
bliss@lumc.nl
+31(0)715263785
Backup
Onderzoekscentrum Psychiatrie, OZC
bliss@lumc.nl
Time Frame
Start Date: 2024-03-13
Estimated Completion Date: 2028-03-01
Participants
Target number of participants: 80
Treatments
BLISS candidates
Adult patients with bipolar disorder (BD) type I or II, who have recently started lithium treatment as part of standard care, will be included. At 12-month follow-up, the longitudinal outcome of lithium treatment will be assessed using a validated questionnaire. Based on previous studies, approximately one-third of participants are expected to be classified as full responders at the 12-month follow-up, with another one-third classified as clinical non-responders to lithium treatment.
Related Therapeutic Areas
Sponsors
Collaborators: GGZ Rivierduinen, PsyQ
Leads: Leiden University Medical Center

This content was sourced from clinicaltrials.gov