Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-06 @ 1:10 PM
Study NCT ID:
NCT05409794
Status:
RECRUITING
Last Update Posted:
2024-08-09
First Post:
2022-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Basal Plasma Lithium Levels and Suicidal Events
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
Official Title:
Basal Plasma Lithium Levels and Suicidal Events (LIPS)
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIPS
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: