Clinical trial Recruiting at 1 site Observational Ages 18 and up

Real-life lithium use in people with bipolar disorder

Official title: Real-world Lithium Intake Measured by a Pillbox: A Clinical Study to Test Real-world Compliance With Lithium Treatment

Run by University of Aarhus · NCT07167563 · Data updated 2026-11-12

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 typeObservational
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorUniversity of Aarhus
Academic / other
Locations1 site (Aarhus)
StatusRecruiting
StartedJuly 5, 2025
Main results expectedJune 30, 2026
Study endsJuly 15, 2026
Registry record updatedSeptember 11, 2025
Trial IDNCT07167563 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Clinic for Bipolar Disorder, Aarhus University Hospital Psychiatry
    Aarhus, Denmark
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.