Real-life lithium use in people with bipolar disorder
Real-world Lithium Intake Measured by a Pillbox: A Clinical Study to Test Real-world Compliance With Lithium Treatment
This project will track daily lithium-taking patterns in adults with bipolar disorder using a smart pill box that timestamps removals plus weekly phone check-ins.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT07167563 on ClinicalTrials.gov |
What this trial studies
This observational project follows adult outpatients with bipolar disorder who are treated with lithium at the Aarhus University Hospital clinic. Participants use a pill box that records the time each lithium tablet is removed as a proxy for actual intake and receive a weekly phone call to report additional details about dosing. No changes to clinical treatment are made; data are collected during routine care to describe adherence patterns and timing of doses. The findings will be used to understand real-world dosing behavior and how it relates to guideline-recommended timing for lithium blood sampling.
Who should consider this trial
Good fit: Adults (≥18) diagnosed with bipolar disorder who are being treated with lithium and followed at the Bipolar Disorder outpatient clinic, and who can give informed consent.
Not a fit: People not taking lithium, those in forensic or coercive care, or patients judged unable by their clinician to participate are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, the results could help clinicians better time blood tests and design adherence supports to keep lithium levels safer and more effective.
How similar studies have performed: Electronic pill-box adherence monitoring has provided useful data in other psychiatric and chronic disease groups, though using it specifically to study lithium timing is relatively uncommon.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years 2. Diagnosed with bipolar disorder (ICD-10: F30-31) 3. Followed at the bipolar disorder outpatient clinic at AUHP 4. Treated with lithium (ATC-code: N05AN01) 5. Able to give informed oral and written consent. Exclusion Criteria: 1. Any coercive measure in the study period including patients in forensic psychiatry. 2. In a clinical condition where the treating clinician evaluates that the patient is not able to attend the research study.
Where this trial is running
Aarhus
- Clinic for Bipolar Disorder, Aarhus University Hospital Psychiatry — Aarhus, Denmark (Recruiting)
Study contacts
- Study coordinator: Ole Köhler-Forsberg, MD, PhD, Assoc. Professor
- Email: karkoe@rm.dk
- Phone: +4578451770
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.