TerminatedNot Applicable

Validation of the French Version of the Lithium Knowledge Test (LKT)

Stopped: Sponsor decision

France22 participantsStarted 2023-11-28

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of the factorial validity of the score from the first completed LKT self-questionnaire

Timeframe: 2 yaers

Trial details

NCT IDNCT06033326

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-11-28

View on ClinicalTrials.gov More Patient Treated With Lithium, With Bipolar or Schizo-affective Disorder, Hospitalized in a Psychiatric Ward trials