CHU Montpellier
Montpellier, France
Location status: Recruiting
Location contact
Benedicte NOBILE
CONTACT
NCT Number: NCT05409794
Suicidal behavior is a major public health issue and there are currently no specific treatments for it.
However, lithium, the reference treatment for bipolar disorder, have been shown to be effective in preventing suicidal risk.
Apart from drug treatments, lithium is present in our environment and its levels varies from one individual to another, depending, especially, on diet.
Knowing that patients with a mood disorder generally have a poor lifestyle and a less rich and varied diet than the general population, variations in basal lithium levels can be expected in these patients.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Montpellier, France
Location status: Recruiting
Benedicte NOBILE
CONTACT
This study aims to assess the rate of depressed patients (unipolar or bipolar) with basal plasma lithium levels above 0.1 µeq/L.
It also aims to :
To do so, 158 patients currently suffering from a major depressive disorder and who have not received any lithium treatment over the last year, will be included and divided in two groups :
Following a clinical assessment, a blood sample will be collected from each participant to measure basal plasma lithium levels.
Study participation will be done in one day.
The investigators expect :
This knowledge will eventually make it possible to develop prevention and management strategies.
More appropriate prevention and management strategies better adapted to patients at risk of suicide.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Blood sample for the determination of plasma lithium levels
Time frame: Baseline
Rate of patients with basal plasma lithium levels, assessed at baseline, above the threshold of 0.1 µeq/L
Time frame: Baseline
Basal plasma lithium levels (µeq/L) assessed in all participants at baseline.
Time frame: Baseline
Severity of current suicidal ideation, assessed with the Columbia Suicide Severity Rating Scale. The ideation severity subscale ranges from 1 to 5 (higher score indicating more severe ideation). The ideation intensity subscale includes 5 questions each ranging from 1 to 5 (higher score indication more intense ideation). The suicidal behavior subscale includes 4 yes/no questions. The suicidal behavior lethality subscale inquires about the level of actual or potential medical damage.
Time frame: Baseline
Impulsiveness assessed with the Barratt Impulsiveness Scale (BIS). The total score ranges from 30 to 120 with a higher score indicating an increased impulsive behavior.
Time frame: Baseline
Aggression assessed with the 12 items Aggression Questionnaire (AQ-12). The questionnaire is divided in 4 subscales of 3 items (physical aggression, verbal aggression, anger, hostility) for each, the score ranges from 3 to 18 with a higher score indicating an increased aggressive behavior
Time frame: Baseline
For patients with bipolar disorder (BD): type of BD, age of onset, rapid cycling over lifetime, number of manic/hypomanic/depressive episodes over lifetime and the last year.
Time frame: Baseline
Emotional lability assessed with the Affective Lability Scale (ALS). The questionnaire is divided in 3 subscales (anxiety/depression, depression/elation and anger). For each subscale, higher score indicates an increased affective lability.
Time frame: Baseline
For patients with a suicide attempt in the year prior to inclusion : number of actual, aborted and interrupted suicide attempts, number of violent and serious attempts.
Contact information is provided by the study sponsor or research team.
University Hospital, Montpellier
Other
Basal Plasma Lithium Levels and Suicidal Events (LIPS)
Acronym: LIPS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06529029
Behavior, Behavioral Symptoms
Grand Rapids, Michigan, United States
View Trial DetailsNCT06462196
Analgesics, Anesthetics
Bethesda, Maryland, United States
View Trial DetailsNCT05786066
Behavior, Behavioral Symptoms
West Haven, Connecticut, United States
View Trial DetailsNCT03898297
Behavior, Behavioral Symptoms
New Haven, Connecticut, United States
View Trial Details