Patient Treated With Lithium, With Bipolar or Schizo-affective Disorder, Hospitalized in a Psychiatric WardLKTNCT06033326
Validation of the French Version of the Lithium Knowledge Test (LKT)
An observational study of Patient Treated With Lithium, With Bipolar or Schizo-affective Disorder, Hospitalized in a Psychiatric Ward, run by University Hospital, Lille at 1 site in France.
Trial summary
Lithium is a drug used to treat several psychiatric illnesses. This medication requires particular vigilance because it has a narrow therapeutic margin: the dose necessary to obtain an effective treatment is close to the toxic dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Treated With Lithium, With Bipolar or Schizo-affective Disorder, Hospitalized in a Psychiatric Ward
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2023to 28 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in an adult psychiatric ward or staying in an EPSM in the cities included in this study
Who may be able to join
- Patient hospitalized in a psychiatric ward or in an EPSM for more than 10 consecutive days
- Patient treated with IR or ER lithium LI
- Patient over 18 years of
- Patient on a fixed dosage of lithium for more than 5 days prior to blood sampling for lithiaemia testing
- Obtain patient's non-opposition
Who cannot join
- Clinically unstable patient or patient with a cognitive disorder that makes it impossible to perform interview and/or completion of the LKT self-questionnaire
- Patients under guardianship or trusteeship
- Illiterate patients
- Patient with a therapeutic target concentration different from general recommendations (e.g. elderly subject)
- Patient receiving a pharmaceutical interview or any other interview between the completion of the 1 and 2nd questionnaires, likely to modify the LKT score.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the French Version of the Lithium Knowledge Test (LKT) for Patients Treated With Lithium in Psychiatric Unit Hospitals
Lithium is a drug used to treat several psychiatric illnesses. This medication requires particular vigilance because it has a narrow therapeutic margin: the dose necessary to obtain an effective treatment is close to the toxic dose.
The blood dosage of the drug and the patient's knowledge of the drug are necessary to optimize and secure the drug intake.
Read more
The objective of this observational study is to confirm that the score obtained by the LKT lithium knowledge self-questionnaire translated into French is representative of the knowledge of patients treated with lithium.
Participants will be asked to complete this questionnaire twice, and the scores obtained will be compared to the blood lithium level to see if a good score is associated with an effective blood lithium concentration.
- Keywords
- Lithium, observance, security, Lithium Knowledge Test
- Medical subject headings
- Psychotic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the factorial validity of the score from the first completed LKT self-questionnaire
Baseline: percentage of inertia explained by the first component of the principal component analysis Maximum time to obtain scores for 300 self-questionnaires: 2 years
Measured: 2 yaers
Secondary outcomes (5)
Evaluation of the internal consistency of the LKT score: is acceptable if Cronbach's alpha is greater than 0.7
Baseline after data collection: percentage of inertia explained by the first component of the principal component analysis Maximum time to obtain scores for 300 self-questionnaires: 2 years
Measured: 2 yaers
External validity of the LKT self-questionnaire by measuring the correlation between the lithiaemia assay at D0 and the score obtained on the self-questionnaire at D0.
Baseline after data collection: percentage of inertia explained by the first component of the principal component analysis Maximum time to obtain scores for 300 self-questionnaires: 2 years
Measured: 2 yaers
Evaluation of the test/retest reliability of the LKT self-questionnaire score measured at D0 and D4.
Baseline and 4 days after data collection Maximum time to obtain scores for 300 self-questionnaires: 2 years
Measured: 2 years
Comparison of lithiaemia at D0 between patients with good knowledge (i.e. a LKT self-questionnaire score at D0 > 6) and those with poor knowledge of treatment
Baseline and 4 days after data collection Maximum time to obtain scores for 300 self-questionnaires: 2 years
Measured: 2 years
Search for factors associated with the LKT self-questionnaire score at J0.
Baseline and 4 days after data collection Maximum time to obtain scores for 300 self-questionnaires: 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start28 Nov 2023
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Treated With Lithium, With Bipolar or Schizo-affective Disorder, Hospitalized in a Psychiatric WardStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033326
- Sponsor's protocol ID
- 2020_98
- Acronym
- LKT
- Status last verified
- May 2026
- First submitted
- 5 Sep 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Version of the Lithium Knowledge Test (LKT) for Patients Treated With Lithium in Psychiatric Unit Hospitals
- ClinicalTrials.gov ID
- NCT06033326
- Acronym / sponsor ID
- LKT / 2020_98
- Keywords
- Lithium, observance, security, Lithium Knowledge Test
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lithium is a drug used to treat several psychiatric illnesses. This medication requires particular vigilance because it has a narrow therapeutic margin: the dose necessary to obtain an effective treatment is close to the toxic dose.
The blood dosage of the drug and the patient's knowledge of the drug are necessary to optimize and secure the drug intake.
The objective of this observational study is to confirm that the score obtained by the LKT lithium knowledge self-questionnaire translated into French is representative of the knowledge of patients treated with lithium.
Participants will be asked to complete this questionnaire twice, and the scores obtained will be compared to the blood lithium level to see if a good score is associated with an effective blood lithium concentration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in an adult psychiatric ward or staying in an EPSM in the cities included in this study
Key inclusion criteria (5 listed)
- Patient hospitalized in a psychiatric ward or in an EPSM for more than 10 consecutive days
- Patient treated with IR or ER lithium LI
- Patient over 18 years of
- Patient on a fixed dosage of lithium for more than 5 days prior to blood sampling for lithiaemia testing
- Obtain patient's non-opposition
Key exclusion criteria (5 listed)
- Clinically unstable patient or patient with a cognitive disorder that makes it impossible to perform interview and/or completion of the LKT self-questionnaire
- Patients under guardianship or trusteeship
- Illiterate patients
- Patient with a therapeutic target concentration different from general recommendations (e.g. elderly subject)
- Patient receiving a pharmaceutical interview or any other interview between the completion of the 1 and 2nd questionnaires, likely to modify the LKT score.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the factorial validity of the score from the first completed LKT self-questionnaire
Time frame: 2 yaers
Baseline: percentage of inertia explained by the first component of the principal component analysis Maximum time to obtain scores for 300 self-questionnaires: 2 years
5 secondary outcomes
Evaluation of the internal consistency of the LKT score: is acceptable if Cronbach's alpha is greater than 0.7
Time frame: 2 yaers
External validity of the LKT self-questionnaire by measuring the correlation between the lithiaemia assay at D0 and the score obtained on the self-questionnaire at D0.
Time frame: 2 yaers
Evaluation of the test/retest reliability of the LKT self-questionnaire score measured at D0 and D4.
Time frame: 2 years
Comparison of lithiaemia at D0 between patients with good knowledge (i.e. a LKT self-questionnaire score at D0 > 6) and those with poor knowledge of treatment
Time frame: 2 years
Search for factors associated with the LKT self-questionnaire score at J0.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Treated With Lithium, With Bipolar or Schizo-affective Disorder, Hospitalized in a Psychiatric Ward, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the factorial validity of the score from the first completed LKT self-questionnaire (time frame: 2 yaers). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.