Pilot trial estimating the correct 12-hour lithium blood concentration

The Estimated 12-Hour Serum Lithium Level Pilot Study

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000034-42-DK

Enrollment

Registered

2022-01-25

Start date

2022-04-22

Completion date

Unknown

Last updated

2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar disorder Unipolar Depression MedDRA version: 20.0 Level: HLT Classification code 10004938 Term: Bipolar disorders System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 21.1 Level: PT Classification code 10057667 Term: Bipolar disorder System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: Lithiumcarbonat Litarex Pharmaceutical Form: Coated tablet INN or Proposed INN: Lithiumcarbonate CAS Number: 554-13-2 Other descriptive name: LITHIUM CARBONATE Concentration unit: mmol mil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age =18 years. 2. Treatment with extended-release or immediate-release lithium formulation. 3. On a stable lithium dose, i.e., no dose change within the last 7 days. 4. Lithium is prescribed as one daily dose administered in the evening and can safely be administered at 20:00 hours in relation to participation in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: 1. Lacking ability to provide informed consent. 2. Any current coercive measure (e.g., involuntarily admission). 3. Hospitalized according to sentence to treatment. 4. Reduced renal clearance, defined as eGFR<90 measured in a blood test taken within one month before the recruitment. 5. Severe mania (as per clinical judgement), as restoration of the sleep pattern is a fundamental part of inpatient treatment in these cases. 6. Clinical condition that precludes participation (e.g., severe suicidality, as per clinical judgement). 7. Pregnancy, tested via a pregnancy test.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the distribution of serum lithium levels during the 24 hours after the most recent lithium dose. ;Secondary Objective: Not applicable;Primary end point(s): The primary study endpoint is whether we can calculate a 12-hour serum lithium level (based on serum lithium evels taken at other time points than 12 hours) within an acceptable range of the measured 12-hour serum lithium level and without giving falsely high or falsely low serum lithium values ;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

Main Objective: To investigate the distribution of serum lithium levels during the 24 hours after the most recent lithium dose. ;Secondary Objective: Not applicable;Primary end point(s): The primary study endpoint is whether we can calculate a 12-hour serum lithium level (based on serum lithium evels taken at other time points than 12 hours) within an acceptable range of the measured 12-hour serum lithium level and without giving falsely high or falsely low serum lithium values ;Timepoint(s) of evaluation of this end point: Not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Denmark

Contacts

Public ContactOle Köhler-Forsberg

Aarhus University Hospital - Psychiatry, Department of Affective Disorders

karkoe@rm.dk004523420661

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026