Идёт набор NCT05409794

Basal Plasma Lithium Levels and Suicidal Events

— Наблюдательное Major Depressive Disorder Suicidal Behavior Bipolar Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Blood sample.
Кому может быть актуально: Состояния в реестре: Major Depressive Disorder, Suicidal Behavior, Bipolar Disorder. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Basal Plasma Lithium Levels and Suicidal Events (LIPS)

Обзор

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.

Подробное описание

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 :

* compare basal plasma lithium levels according to the occurrence of a suicidal event in the year prior to inclusion ; * assess the association of lithium levels with the intensity of current suicidal ideation ; * assess the association of lithium levels with impulsiveness ; * assess the association of lithium levels with characteristics of bipolar disorder (for patients with bipolar disorder) ; * assess the association of lithium levels with emotional lability ; * assess, in the patients with a suicidal event in the year prior to the inclusion, the association of lithium levels with the characteristics of suicide attempts

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 :

1. Depressed patients with a history of suicidal event over the last 12 months (suicide attempters/ideations) ; 2. Depressed patients with no history of suicidal event over the last 12 months (affective controls).

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 :

1. an inverse association between lithium levels and suicidal events in patients 2. an inverse association between lithium levels and impulsiveness and aggression in patients This study will contribute to a better knowledge on suicidal behavior, especially by confirming the protective effect of lithium and improving the understanding of the mechanisms involved.

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.

Вмешательства

Биопрепарат Blood sample
Blood sample for the determination of plasma lithium levels

Первичные конечные точки

Patients rate with lithium levels above 0.1 µeq/L [Срок оценки: Baseline]

Вторичные конечные точки (7)

Basal plasma lithium levels [Срок оценки: Baseline]
Current suicidal ideation [Срок оценки: Baseline]
Impulsiveness level [Срок оценки: Baseline]
Aggression level [Срок оценки: Baseline]
Bipolar disorder characteristics [Срок оценки: Baseline]
Emotional lability [Срок оценки: Baseline]
Suicide attempt characteristics [Срок оценки: Baseline]

Критерии участия

Критерии включения

18 years old or over
Current major depressive episode according to the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria
No lithium-based treatment over the last 12 months
For suicide attempters/ideations only : suicidal event over the last 12 months
For affective controls only : no suicidal event over the last 12 months