Feasibility of eLi12

NCT07306039 | Active Not Recruiting

• 1 other identifier: 2025_eLi12
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Bipolar Disorder (BD)

Keywords

Lithium; Trough level; Clinical feasibility; eLi12

Outcome Measures

Primary Outcomes (3)

• The percentage of patients registering the time since the last lithium dose

  Each patient participates from the individual randomization date and up to 24 months. Follow-up ends when a participant wants to leave the study or at the end of the study on December 31, 2027

• The difference between eLi12 and Se-Li

  For each lithium blood test, the difference between the measured Se-Li concentration and the estimated eLi12 level (i.e. for the same blood test based on the patient-reported time since last lithium intake and the Se-Li concentration)

  Each patient participates from the individual randomization date and up to 24 months. Follow-up ends when a participant wants to leave the study or at the end of the study on December 31, 2027

• for those periods of time where participants have no change in their lithium dose, the variation in eLi12 compared to the actual measured lithium concentrations at ≤10 hours or ≥14 hours from the last dose

  Each patient participates from the individual randomization date and up to 24 months. Follow-up ends when a participant wants to leave the study or at the end of the study on December 31, 2027

Secondary Outcomes (3)

• questionnaires filled out before and after participation in the study by the participants whether they prefer a solution as eLi12 that gives more flexibility with regards to timing of lithium blood tests

  Each patient participates from the individual randomization date and up to 24 months. Follow-up ends when a participant wants to leave the study or at the end of the study on December 31, 2027

• questionnaires filled out regularly by the attending clinicians reporting whether eLi12 is a safe and intuitive solution

  Each patient participates from the individual randomization date and up to 24 months. Follow-up ends when a participant wants to leave the study or at the end of the study on December 31, 2027

• changes on questionnaires filled out by participants before and after the study measuring self-reported symptoms (HAMD-6 and Altman-5), side effects (ASAQ), quality of life (EQ-5D-5L) and work productivity/activity impairment (WPAI).

  Each patient participates from the individual randomization date and up to 24 months. Follow-up ends when a participant wants to leave the study or at the end of the study on December 31, 2027

Study Arms (2)

Participants will have shown eLi12

ACTIVE COMPARATOR

Participants and their treating clinicians will have shown eLi12, the estimated 12-hour lithium concentration, in the electronic patient journal on top of the usual Se-Li concentration

Procedure: Participants will have shown eLi12

Participants will not have shown eLi12

PLACEBO COMPARATOR

Participants will not have shown eLi12, the estimated 12-hour lithium concentration, in the electronic patient journal but only the usual Se-Li concentration

Procedure: Participants will not have shown eLi12

Interventions

Participants will have shown eLi12 PROCEDURE

Participants will have shown eLi12, the estimated 12-hour lithium level, in the electronic patient journal

Participants will have shown eLi12

Participants will not have shown eLi12 PROCEDURE

Participants will not have shown eLi12, the estimated 12-hour lithium level, in the electronic patient journal

Participants will not have shown eLi12

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ole Köhler-Forsberg: lead
• Randers Regional Hospital: collaborator
• Gødstrup Hospital: collaborator

Study Sites (3)

Clinic for Bipolar Disorder, Aarhus University Hospital Psychiatry

Aarhus, Denmark

Location

Psychiatric Hospital Gødstrup

Herning, Denmark

Location

Psychiatric Hospital Randers

Randers, Denmark

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Model Details: Participants will be randomized to have shown eLi12 (the estimated 12-hour lithium blood concentration) or not. All participants will have shown usual lithium concentration

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 29, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)