Bipolar Disorder I or IIBLISSNCT06134349
The Bipolar Lithium Imaging Scan Study.
An observational study of Bipolar Disorder I or II, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder I or II
- What is being tested?
- Lithium MR imaging
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Mar 2024to 1 Mar 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with bipolar disorder type I or II who start with lithium treatment as part of standard care.
Who may be able to join
- 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.
Who cannot join
- 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
- meeting any exclusion criterium for MR imaging.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Onderzoekscentrum Psychiatrie, OZC contact
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
E Boere, MD, +31715263785, bliss@lumc.nl
About this study
Official title: The Bipolar Lithium Imaging Scan Study: Imaging Lithium in the Brains of Subjects with Bipolar Disorder
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.
Read the detailed description
Introduction Lithium treatment is considered the first-line pharmacological treatment for bipolar disorder. However, individual responses vary greatly, which undermines the ability to achieve rapid stabilization in many patients with bipolar disorder. The neurobiological mechanisms underlying lithium's action are still largely unknown, which hampers the development of clinically applicable predictors for individual treatment response. The recent introduction of ultra-high-field lithium magnetic resonance imaging offers a promising avenue to better link brain measures with clinical responses to lithium treatment.
Methods and Analysis This is a longitudinal observational study involving 80 adults with bipolar disorder who are initiating lithium as part of their regular treatment regimen. Ultra-high-field lithium magnetic resonance imaging of the brain will be performed within four weeks of reaching stable therapeutic serum lithium concentrations. The primary outcome is clinical response to lithium treatment at one-year follow-up, as measured using a validated questionnaire. Linear regression analysis will be used to establish correlations between brain lithium concentrations-including whole brain, voxel-wise, parcellation, mean, and region-of-interest approaches-and clinical lithium response.
- Conditions
- Bipolar Disorder I or II
- Being tested
- Lithium MR imaging
- Keywords
- bipolar disorder, lithium, lithium MR imaging, ultra-high field imaging, clinical response, clinical, 7 Tesla
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithium MR imagingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Lithium MR imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical lithium response
Clinical lithium response will be assessed using a validated questionnaire.
Measured: At 12-month follow-up.
Secondary outcomes (1)
Serum lithium concentrations
Serum lithium concentrations will be determined to establish correlations with brain lithium concentrations.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start13 Mar 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar Disorder I or IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- PsyQ, GGZ Rivierduinen
- Responsible party
- Principal investigator, mleeuw, Leiden University Medical Center
- Investigators
- E Boere, MD, Study chair, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134349
- Sponsor's protocol ID
- NL80214.058.22
- Acronym
- BLISS
- Status last verified
- Dec 2024
- First submitted
- 8 Nov 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Lithium MR imaging data.
Publications
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.
PubMed 40160802
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bipolar Lithium Imaging Scan Study: Imaging Lithium in the Brains of Subjects with Bipolar Disorder
- ClinicalTrials.gov ID
- NCT06134349
- Acronym / sponsor ID
- BLISS / NL80214.058.22
- Conditions
- Bipolar Disorder I or II
- Keywords
- bipolar disorder, lithium, lithium MR imaging, ultra-high field imaging, clinical response, clinical, 7 Tesla
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- PsyQ, GGZ Rivierduinen
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction Lithium treatment is considered the first-line pharmacological treatment for bipolar disorder. However, individual responses vary greatly, which undermines the ability to achieve rapid stabilization in many patients with bipolar disorder. The neurobiological mechanisms underlying lithium's action are still largely unknown, which hampers the development of clinically applicable predictors for individual treatment response. The recent introduction of ultra-high-field lithium magnetic resonance imaging offers a promising avenue to better link brain measures with clinical responses to lithium treatment.
Methods and Analysis This is a longitudinal observational study involving 80 adults with bipolar disorder who are initiating lithium as part of their regular treatment regimen. Ultra-high-field lithium magnetic resonance imaging of the brain will be performed within four weeks of reaching stable therapeutic serum lithium concentrations. The primary outcome is clinical response to lithium treatment at one-year follow-up, as measured using a validated questionnaire. Linear regression analysis will be used to establish correlations between brain lithium concentrations-including whole brain, voxel-wise, parcellation, mean, and region-of-interest approaches-and clinical lithium response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BLISS candidates | – | Other: Lithium MR imagingAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with bipolar disorder type I or II who start with lithium treatment as part of standard care.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
- meeting any exclusion criterium for MR imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lithium MR imagingAfter 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. | Other | BLISS candidates |
Primary outcome
Clinical lithium response
Time frame: At 12-month follow-up.
Clinical lithium response will be assessed using a validated questionnaire.
1 secondary outcome
Serum lithium concentrations
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Derived from this study: PubMed 40160802Boere 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.
- Individual participant dataSharing planned: Yes. Lithium MR imaging data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Onderzoekscentrum Psychiatrie, OZC contact
E Boere, MD study chair
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder I or II, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact E Boere (+31(0)715263785, bliss@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical lithium response (time frame: At 12-month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06134349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.