Major Depressive Disorder Clinical Trial
— LIPSOfficial title:
Basal Plasma Lithium Levels and Suicidal Events (LIPS)
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.
Status | Recruiting |
Enrollment | 158 |
Est. completion date | July 9, 2025 |
Est. primary completion date | July 9, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Montpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patients rate with lithium levels above 0.1 µeq/L | Rate of patients with basal plasma lithium levels, assessed at baseline, above the threshold of 0.1 µeq/L | Baseline | |
Secondary | Basal plasma lithium levels | Basal plasma lithium levels (µeq/L) assessed in all participants at baseline. | Baseline | |
Secondary | Current suicidal ideation | 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. | Baseline | |
Secondary | Impulsiveness level | 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. | Baseline | |
Secondary | Aggression level | 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 | Baseline | |
Secondary | Bipolar disorder characteristics | 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. | Baseline | |
Secondary | Emotional lability | 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. | Baseline | |
Secondary | Suicide attempt characteristics | 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. | Baseline |
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