Basal Plasma Lithium Levels and Suicidal Events

NCT ID: NCT05409794

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 158 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-09
• Study Completion Date: 2027-01-09

Brief Summary

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.

Detailed Description

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.

Conditions

Major Depressive Disorder; Suicidal Behavior; Bipolar Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Suicide attempters/ideations

Patients currently suffering from a major depressive disorder and reporting at least one suicidal event (suicide attempt or hospitalization for suicidal ideation) over the last 12 months.

Blood sample

Intervention Type: BIOLOGICAL

Blood sample for the determination of plasma lithium levels

Affective controls

Patients currently suffering from a major depressive disorder and reporting no suicidal event (suicide attempt or hospitalization for suicidal ideation) over the last 12 months.

Blood sample

Intervention Type: BIOLOGICAL

Blood sample for the determination of plasma lithium levels

Interventions

Blood sample

Blood sample for the determination of plasma lithium levels

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Lifetime diagnosis of schizoaffective disorder, schizophrenia or psychosis
• Pregnancy or breastfeeding
• Deprivation of freedom (by judicial or administrative decision)
• Legal protection measure (guardianship or curators)
• Inability to understand experimental procedures
• No affiliation to the French National Social Security System
• No consent to participate in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Montpellier

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Bénédicte NOBILE, Pharma D, PhD

Role: CONTACT

b-nobile@chu-montpellier.fr

+33467338581

Facility Contacts

Benedicte NOBILE

Role: primary

Other Identifiers

RECHMPL22_0039

Identifier Type: -

Identifier Source: org_study_id