Bipolar Disorder (BD)NCT07167563
Real-world Lithium Intake
An observational study of Bipolar Disorder (BD), run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of the present study is to study compliance with lithium therapy and patterns of lithium intake among a representative group of patients with bipolar disorder in a real-world clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder (BD)
- What is being tested?
- Lithium (LI) based on clinical indication
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Jul 2025to 15 Jul 2026
- 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: Any patient aged ≥18 years diagnosed with bipolar disorder followed at the bipolar disorder outpatient unit at AUHP, treated with lithium and without any coercive measure or forensic psychiatry sanction at the time of inclusion will be eligible for inclusion in the study.
Who may be able to join
- Age ≥18 years
- Diagnosed with bipolar disorder (ICD-10: F30-31)
- Followed at the bipolar disorder outpatient clinic at AUHP
- Treated with lithium (ATC-code: N05AN01)
- Able to give informed oral and written consent.
Who cannot join
- Any coercive measure in the study period including patients in forensic psychiatry.
- In a clinical condition where the treating clinician evaluates that the patient is not able to attend the research study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Clinic for Bipolar Disorder, Aarhus University Hospital Psychiatry
Aarhus
Ole Köhler-Forsberg, +4578451770, karkoe@rm.dk
About this study
Official title: Real-world Lithium Intake Measured by a Pillbox: A Clinical Study to Test Real-world Compliance With Lithium Treatment
The aim of the present study is to study compliance with lithium therapy and patterns of lithium intake among a representative group of patients with bipolar disorder in a real-world clinical setting. This will be studied via a pill box that registers the daily time when the participant took the lithium tablet out of the pill box, representing a proxy for the actual lithium intake. Participants will receive a weekly phone call asking for several aspects of lithium intake.
Read the detailed description
Bipolar disorder is a severe mental disorder1 and lithium represents the first-line pharmacological treatment1-5. The individual lithium dose is based on monitoring of clinical effect and lithium blood levels6,7 (i.e., plasma lithium (P-Li) levels), which can be measured easily and accurately via blood sampling. Treatment guidelines recommend measuring P-Li levels during up-titration, but also regularly (2-4x/year) when patients have reached a stable dose6-8. P-Li levels are also measured to avoid high blood levels that are associated with side effects. Specifically, it is well-known that lithium can have adverse effects on the kidneys9-11 and the thyroid gland11, and that the therapeutic window is relatively narrow6.
P-Li levels reach a peak concentration after 2-4 hours, following which the concentration steadily decreases, as lithium is excreted entirely through the kidneys6. Treatment guidelines have for >50 years recommended that P-Li levels should be measured 12 hours after the patient has taken the most recent lithium dose in order to evaluate the target P-Li and lithium dose for each individual patient6,7,12, allowing a time window from 10 to 14 hours after lithium intake6,7,13,14. Typically, patients take the lithium dose in the evening and the blood sample is collected the following morning before a potential morning dose of lithium is taken. As the vast majority of lithium-treated patients are outpatients, this 12-hour timing depends entirely on the patient, meaning that the patient is responsible to get the blood test 12 hours after the most recent lithium intake. However, patients may have difficulties to get the lithium blood test taken 12 hours after the lithium dose15, blood sampling may be delayed for logistic reasons, and/or patients forget about the specific timing. Hence, P-Li levels may not necessarily reflect the actual 12-hour P-Li level and this complicates clinical decision-making. Indeed, initial data from Central Denmark Region have indicated that 50-75% of lithium-treated patients may not comply with the 12-hour lithium blood test requirement16. This has a potential high impact as e.g., a P-Li level measured 16 hours after the last lithium dose, but interpreted as a 12-hour P-Li level, may lead to an unwarranted increase of the lithium dose, potentially increasing the risk for side effects.
We have developed a new method to estimate the 12-hour P-Li level, termed eLi12 (estimated lithium level at 12 hours). eLi12 is a mathematical equation that can estimate the 12-hour P-Li when the lithium blood test is taken at a different time point, e.g., 8 or 16 hours. This method would represent a solution for the abovementioned clinical challenge but depends on the patient-reported time for lithium intake. As the time point of the lithium blood test always is registered, eLi12 depends on that the patient takes the prescribed lithium dose and correctly reports the time for intake of the most recent lithium intake before the lithium blood test. However, despite that the self-reported time for lithium intake has been used for >50 years in everyday clinical treatment, no study has investigated the pattern on lithium intake in a real-world clinical setting.
- Conditions
- Bipolar Disorder (BD)
- Being tested
- Lithium (LI) based on clinical indication
- Keywords
- Lithium
- 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 (LI) based on clinical indicationOther
Participants have for 4 weeks a pill box registering the time for lithium intake. Weekly phone calls will assess whether patients can remember the time for lithium intake.
| Study group | Role | What they receive |
|---|---|---|
| Patients with bipolar disorder treated with lithium | Not described Receives: Other: Lithium (LI) based on clinical indication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with lithium therapy
Study if patients take their lithium medication on a daily basis, which is measured via a pillbox that registers the time for lithium intake (used for 4 weeks by each participant)
Measured: From enrollment for 4 weeks
Regular intake
Study whether lithium-treated patients take their lithium medication at the same time of day, meaning within 30 minutes of the same time point (measured for 4 weeks via a pillbox containing the lithium medication)
Measured: From enrollment for 4 weeks
The mean time in minutes between the self-reported time for intake of the most recent lithium dose (mentioned at the weekly phone call) and the registered time for the actual intake of the most recent lithium dose (i.e., the most recent intake of lithium
Measured: From enrollment for 4 weeks
If a larger deviation between the self-reported and the registered time for lithium intake (i.e. the measure from co-primary outcome 3) depends on if participants are in a (hypo)manic or depressive mood state (which is answered at the weekly phone call).
Measured: From enrollment for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start5 Jul 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder (BD)Studies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167563
- Sponsor's protocol ID
- 2025_01_eLi12
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Not possible due to local data protection rules.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Lithium Intake Measured by a Pillbox: A Clinical Study to Test Real-world Compliance With Lithium Treatment
- ClinicalTrials.gov ID
- NCT07167563
- Acronym / sponsor ID
- 2025_01_eLi12
- Conditions
- Bipolar Disorder (BD)
- Keywords
- Lithium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 5 Jul 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 11 Sep 2025 (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 aim of the present study is to study compliance with lithium therapy and patterns of lithium intake among a representative group of patients with bipolar disorder in a real-world clinical setting. This will be studied via a pill box that registers the daily time when the participant took the lithium tablet out of the pill box, representing a proxy for the actual lithium intake. Participants will receive a weekly phone call asking for several aspects of lithium intake.
Detailed description
Bipolar disorder is a severe mental disorder1 and lithium represents the first-line pharmacological treatment1-5. The individual lithium dose is based on monitoring of clinical effect and lithium blood levels6,7 (i.e., plasma lithium (P-Li) levels), which can be measured easily and accurately via blood sampling. Treatment guidelines recommend measuring P-Li levels during up-titration, but also regularly (2-4x/year) when patients have reached a stable dose6-8. P-Li levels are also measured to avoid high blood levels that are associated with side effects. Specifically, it is well-known that lithium can have adverse effects on the kidneys9-11 and the thyroid gland11, and that the therapeutic window is relatively narrow6.
P-Li levels reach a peak concentration after 2-4 hours, following which the concentration steadily decreases, as lithium is excreted entirely through the kidneys6. Treatment guidelines have for >50 years recommended that P-Li levels should be measured 12 hours after the patient has taken the most recent lithium dose in order to evaluate the target P-Li and lithium dose for each individual patient6,7,12, allowing a time window from 10 to 14 hours after lithium intake6,7,13,14. Typically, patients take the lithium dose in the evening and the blood sample is collected the following morning before a potential morning dose of lithium is taken. As the vast majority of lithium-treated patients are outpatients, this 12-hour timing depends entirely on the patient, meaning that the patient is responsible to get the blood test 12 hours after the most recent lithium intake. However, patients may have difficulties to get the lithium blood test taken 12 hours after the lithium dose15, blood sampling may be delayed for logistic reasons, and/or patients forget about the specific timing. Hence, P-Li levels may not necessarily reflect the actual 12-hour P-Li level and this complicates clinical decision-making. Indeed, initial data from Central Denmark Region have indicated that 50-75% of lithium-treated patients may not comply with the 12-hour lithium blood test requirement16. This has a potential high impact as e.g., a P-Li level measured 16 hours after the last lithium dose, but interpreted as a 12-hour P-Li level, may lead to an unwarranted increase of the lithium dose, potentially increasing the risk for side effects.
We have developed a new method to estimate the 12-hour P-Li level, termed eLi12 (estimated lithium level at 12 hours). eLi12 is a mathematical equation that can estimate the 12-hour P-Li when the lithium blood test is taken at a different time point, e.g., 8 or 16 hours. This method would represent a solution for the abovementioned clinical challenge but depends on the patient-reported time for lithium intake. As the time point of the lithium blood test always is registered, eLi12 depends on that the patient takes the prescribed lithium dose and correctly reports the time for intake of the most recent lithium intake before the lithium blood test. However, despite that the self-reported time for lithium intake has been used for >50 years in everyday clinical treatment, no study has investigated the pattern on lithium intake in a real-world clinical setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with bipolar disorder treated with lithium | – | Other: Lithium (LI) based on clinical indication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient aged ≥18 years diagnosed with bipolar disorder followed at the bipolar disorder outpatient unit at AUHP, treated with lithium and without any coercive measure or forensic psychiatry sanction at the time of inclusion will be eligible for inclusion in the study.
Key inclusion criteria (5 listed)
- Age ≥18 years
- Diagnosed with bipolar disorder (ICD-10: F30-31)
- Followed at the bipolar disorder outpatient clinic at AUHP
- Treated with lithium (ATC-code: N05AN01)
- Able to give informed oral and written consent.
Key exclusion criteria (2 listed)
- Any coercive measure in the study period including patients in forensic psychiatry.
- In a clinical condition where the treating clinician evaluates that the patient is not able to attend the research study.
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 (LI) based on clinical indicationParticipants have for 4 weeks a pill box registering the time for lithium intake. Weekly phone calls will assess whether patients can remember the time for lithium intake. | Other | Patients with bipolar disorder treated with lithium |
Primary outcome
Compliance with lithium therapy
Time frame: From enrollment for 4 weeks
Study if patients take their lithium medication on a daily basis, which is measured via a pillbox that registers the time for lithium intake (used for 4 weeks by each participant)
Regular intake
Time frame: From enrollment for 4 weeks
Study whether lithium-treated patients take their lithium medication at the same time of day, meaning within 30 minutes of the same time point (measured for 4 weeks via a pillbox containing the lithium medication)
The mean time in minutes between the self-reported time for intake of the most recent lithium dose (mentioned at the weekly phone call) and the registered time for the actual intake of the most recent lithium dose (i.e., the most recent intake of lithium
Time frame: From enrollment for 4 weeks
If a larger deviation between the self-reported and the registered time for lithium intake (i.e. the measure from co-primary outcome 3) depends on if participants are in a (hypo)manic or depressive mood state (which is answered at the weekly phone call).
Time frame: From enrollment for 4 weeks
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 11 Sep 2025.
- Individual participant dataSharing planned: No. Not possible due to local data protection rules.
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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.
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 (BD), run by University of Aarhus at 1 site in Denmark.
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 5 inclusion and 2 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 11 Sep 2025. 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 Denmark. 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 Ole Köhler-Forsberg, MD, PhD, Assoc. Professor (+4578451770, karkoe@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with lithium therapy (time frame: From enrollment for 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2025.