Pilot trial estimating the correct 12-hour lithium blood concentratio

Phase 1

• Conditions: Bipolar disorder Unipolar Depression; MedDRA version: 20.0Level: HLTClassification code 10004938Term: Bipolar disordersSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 21.1Level: PTClassification code 10057667Term: Bipolar disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2022-000034-42-DK
• Lead Sponsor: Aarhus University Hospital - Psychiatry, Department of Affective Disorders

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-25
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the distribution of serum lithium levels during the 24 hours after the most recent lithium dose. <br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable