The Bipolar Lithium Imaging Scan Study.

NCT06134349 | Recruiting

• 1 other identifier: NL80214.058.22
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder I or II

Keywords

bipolar disorder; lithium; lithium MR imaging; ultra-high field imaging; clinical response; clinical; 7 Tesla

Outcome Measures

Primary Outcomes (1)

• Clinical lithium response

  Clinical lithium response will be assessed using a validated questionnaire.

  At 12-month follow-up.

Secondary Outcomes (1)

• Serum lithium concentrations

  Baseline

Other Outcomes (1)

• Manic and depressive symptom severity

  Baseline

Study Arms (1)

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.

Other: Lithium MR imaging

Interventions

Lithium MR imaging OTHER

After obtaining written informed consent and within four weeks of reaching a stable therapeutic serum lithium concentration, lithium MR imaging will be performed using a 7 Tesla MR system (Achieva, Philips Medical Systems, Eindhoven, The Netherlands) with a dual-tuned 7Li/1H volume head coil (RAPID Biomedical GmbH, Rimpar, Germany). Various approaches, including whole-brain, voxel-wise, parcellation, mean, and regions of interest, will be applied to measure lithium concentrations.

BLISS candidates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with bipolar disorder type I or II who start with lithium treatment as part of standard care.

You may qualify if:

• 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.

You may not qualify if:

• insufficient comprehension of the Dutch language,
• unable to provide informed consent,
• drug or alcohol abuse over a period of two weeks prior to study participation, and

Sponsors & Collaborators

• Leiden University Medical Center: lead
• PsyQ: collaborator
• GGZ Rivierduinen: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

Related Publications (1)

• Boere E, van der Wee NJA, van Hemert AM, Webb AG, de Leeuw M. The Bipolar Lithium Imaging Scan Study (BLISS): protocol for a 7T lithium-7 magnetic resonance study in bipolar disorder. Psychoradiology. 2025 Mar 7;5:kkaf003. doi: 10.1093/psyrad/kkaf003. eCollection 2025.

  PMID: 40160802 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• E Boere, MD

  Leiden University Medical Center

  STUDY CHAIR

Central Study Contacts

E Boere

CONTACT

+31(0)715263785; bliss@lumc.nl

Onderzoekscentrum Psychiatrie, OZC

CONTACT

bliss@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 18, 2023
• Study Start: March 13, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: Study protocol - currently submitted for OA publication CSR - after termination of the BLISS study Analytic code - after termination of the BLISS study IPD - after termination of the BLISS study
• Access Criteria: Study protocol - open access CSR and analytic code - open access IPD: lithium imaging data will be made available upon request with the study chair, and no sooner then after study termination.

Locations

NL (1)