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    Clinical Trial Results:
    The Estimated 12-Hour Serum Lithium Level Pilot Study

    Summary
    EudraCT number
    		 2022-000034-42
    Trial protocol
    		 DK  
    Global end of trial date
    27 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Oct 2024
    First version publication date
    15 Oct 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2022-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital Psychiatry
    Sponsor organisation address
    Palle Juul-Jensens, Aarhus, Denmark,
    Public contact
    Ole Köhler-Forsberg, Aarhus University Hospital - Psychiatry, Department of Affective Disorders, 0045 23420661, karkoe@rm.dk
    Scientific contact
    Ole Köhler-Forsberg, Aarhus University Hospital - Psychiatry, Department of Affective Disorders, 0045 23420661, karkoe@rm.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Jun 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 May 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the distribution of serum lithium levels during the 24 hours after the most recent lithium dose.
    Protection of trial subjects
    Trial participation involved 9 blood tests over a period of 24 hours, including late at night and early morning. For each participant, we evaluated whether it was necessary to wake patients early in the morning. If it was deemed unsafe for the participant, we skipped this blood test.
    Background therapy
    		 Treatment-as-usual based on clinical indication
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Apr 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    21
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients on a stable dose of lithium

    Pre-assignment
    Screening details
    		 1. Age ≥18 years. 2. Treatment with lithium. 3. On a stable lithium dose, i.e., no dose change within the past 5 days. 4. Lithium prescribed as one daily dose administered in the evening.

    Period 1
    Period 1 title
    eLi12 validation trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Lithium
    Arm description
    		 On a stable dose of lithium
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lithium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Stable dose of lithium, no predefined dose. The individual dose was based on clinical indication.

    Number of subjects in period 1
    		Lithium
    Started
    23
    Completed
    23

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    eLi12 validation trial
    Reporting group description
    		 -

    Reporting group values
    		 eLi12 validation trial Total
    Number of subjects
    		 23 23
    Age categorical
    Participants were aged between 21 and 72 years. Mean age 41.6 years.
    Units: Subjects
        Adults 18-72 years
    		 23 23
    Gender categorical
    14 participants were females, 9 were males
    Units: Subjects
        Female
    		 14 14
        Male
    		 9 9
    Subject analysis sets

    Subject analysis set title
    Analysis on all participants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    When including all blood tests (excluding those at 0 and 12 hours), the mean difference from the measured se-Li compared to the 12-hour se-Li level was 0.14 mEq/L, while the difference was 0.07 mEq/L for eLi12 (p<0.0001). The difference between the measured se-Li and the 12-hour level was larger at the more extreme time points, e.g., at 4, 19 or 20 hours, with eLi12 being notably closer to the 12-hour se-Li level even at these extreme time points. For example, after 20 hours, the measured mean se-Li was 0.21 (34%) lower than the 12-hour se-Li level, while the mean eLi12 was only 0.07 (12%) lower. Among blood tests taken between 3 and 24 hours after the most recent lithium dose, 99 out of 102 (97%) eLi12 estimations were closer to the 12-hour se-Li compared to the measured se-Li concentrations. At no time point did eLi12 estimate an unexpectedly high 12-hour se-Li level.

    Subject analysis sets values
    		 Analysis on all participants
    Number of subjects
    23
    Age categorical
    Participants were aged between 21 and 72 years. Mean age 41.6 years.
    Units: Subjects
        Adults 18-72 years
    23
    Age continuous
    Units:
        
    ( )
    Gender categorical
    14 participants were females, 9 were males
    Units: Subjects
        Female
    14
        Male
    9

    End points

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    End points reporting groups
    Reporting group title
    Lithium
    Reporting group description
    		 On a stable dose of lithium

    Subject analysis set title
    Analysis on all participants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    When including all blood tests (excluding those at 0 and 12 hours), the mean difference from the measured se-Li compared to the 12-hour se-Li level was 0.14 mEq/L, while the difference was 0.07 mEq/L for eLi12 (p<0.0001). The difference between the measured se-Li and the 12-hour level was larger at the more extreme time points, e.g., at 4, 19 or 20 hours, with eLi12 being notably closer to the 12-hour se-Li level even at these extreme time points. For example, after 20 hours, the measured mean se-Li was 0.21 (34%) lower than the 12-hour se-Li level, while the mean eLi12 was only 0.07 (12%) lower. Among blood tests taken between 3 and 24 hours after the most recent lithium dose, 99 out of 102 (97%) eLi12 estimations were closer to the 12-hour se-Li compared to the measured se-Li concentrations. At no time point did eLi12 estimate an unexpectedly high 12-hour se-Li level.

    Primary: eLi12

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    End point title
    		 eLi12
    End point description
    The primary endpoint was whether eLi12 could estimate a 12-hour se-Li level within an acceptable range of the measured 12-hour se-Li level without giving falsely high or low se-Li values. All se-Li data from participants with a measured se-Li level at 12 hours and at least one other time point was included for analyses.
    End point type
    Primary
    End point timeframe
    For ewach participant, we took blood tests during 24 hours after the lithium dose.
    End point values
    		 Lithium Analysis on all participants
    Number of subjects analysed
    23
    23
    Units: mEq/L
        number (not applicable)
    23
    23
    Statistical analysis title
    		 Statistical analyses
    Comparison groups
    Lithium v Analysis on all participants
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 0.08
    Variability estimate
    Standard deviation
    Dispersion value
    0.01

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During participation and the subsequent 3 days.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no non-serious adverse events

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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