NCT07306039Active, not recruiting
Feasibility of eLi12
Feasibility of eLi12 in a Clinical Setting
Source: ClinicalTrials.gov · Last updated 29 Dec 2025
Brief summary (registry, in English)
eLi12 represents a new method to estimate the serum-lithium (Se-Li) concentration at 12 hours after the most recent lithium dose. eLi12 is a mathematical equation that presents the clinician with an estimated 12-hour Se-Li level when the lithium blood test is not taken 12 hours after the most recent lithium dose, but e.g., after 8 or 16 hours. The eLi12 equation is based on a development study and supported by two independent proof-of-concept studies. In these studies, eLi12 estimated a Se-Li concentration that was significantly closer to the 12-hour Se-Li level compared to the actual measured Se-Li in all scenarios between 3 hours and 24 hours after the most recent lithium dose. Before eLi12 can be implemented into a clinical setting, it needs to be tested whether lithium-treated patients actually can register the time for the last lithium intake (prerequisite for eLi12) and if eLi12 can provide improvements for everyday clinical work. The objective of this study is to test 1) whether lithium-treated patients can register the time of the most recent lithium intake at the time of their lithium blood test (which is a necessary data point for the eLi12 equation), 2) the difference between eLi12 and Se-Li, 3) if eLi12 will have less variation compared to the actual measured Se-Li concentrations, 4) patient satisfaction with the eLi12 solution and self-reported symptoms, and 5) clinician satisfaction with the eLi12 solution.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 3 Dec 2025
- Start date
- 3 Dec 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Ole Köhler-Forsberg
- Diseases
- Bipolar disorder
- NCT number
- NCT07306039
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 3 Dec 2025 to the primary completion date, 31 Dec 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- In a clinical condition where the treating clinician evaluates that the patient is not able to attend the research study.
Other
- Any coercive measure in the study period including patients in forensic psychiatry
Who the study is looking for
- Age ≥18 years
- Diagnosed with bipolar disorder (ICD-10: F30-31)
- Followed at the bipolar disorder outpatient clinic at AUHP, the outpatient clinic for affective disorders at Randers Psychiatric hospital, or the outpatient clinic for affective disorders at Gødstrup Psychiatric hospital
- Treated with lithium (ATC-code: N05AN01)
- Able to give informed oral and written consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinic for Bipolar Disorder, Aarhus University Hospital Psychiatry Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Psychiatric Hospital Gødstrup Coordinator of this site? Confirm its status | Herning | Denmark | Unknown status |
| Psychiatric Hospital Randers Coordinator of this site? Confirm its status | Randers | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.