Real-world Lithium Intake

NCT07167563 | Recruiting FDA Drug

• 1 other identifier: 2025_01_eLi12
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bipolar Disorder (BD)

Keywords

Lithium

Outcome Measures

Primary Outcomes (4)

• 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)

  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)

  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

  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).

  From enrollment for 4 weeks

Study Arms (1)

Patients with bipolar disorder treated with lithium

Other: Lithium (LI) based on clinical indication

Interventions

Lithium (LI) based on clinical indication OTHER

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.

Patients with bipolar disorder treated with lithium

Eligibility Criteria

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

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.

You may qualify if:

• 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.

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

• University of Aarhus: lead

Study Sites (1)

Clinic for Bipolar Disorder, Aarhus University Hospital Psychiatry

Aarhus, Denmark

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lithium

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Central Study Contacts

Ole Köhler-Forsberg, MD, PhD, Assoc. Professor

CONTACT

+4578451770; karkoe@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 11, 2025
• Study Start: July 5, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)