Basal Plasma Lithium Levels and Suicidal Events (LIPS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- Patients rate with lithium levels above 0.1 µeq/L
Study Overview
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 :
- Depressed patients with a history of suicidal event over the last 12 months (suicide attempters/ideations) ;
- Depressed patients with no history of suicidal event over the last 12 months (affective controls).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Patients rate with lithium levels above 0.1 µeq/L
Time Frame: Baseline
Rate of patients with basal plasma lithium levels, assessed at baseline, above the threshold of 0.1 µeq/L
Secondary Outcomes
- Bipolar disorder characteristics(Baseline)
- Current suicidal ideation(Baseline)
- Basal plasma lithium levels(Baseline)
- Impulsiveness level(Baseline)
- Aggression level(Baseline)
- Suicide attempt characteristics(Baseline)
- Emotional lability(Baseline)