Health TrialsbyHealthPanel

Basal Plasma Lithium Levels and Suicidal Events

ConditionsMajor Depressive DisorderSuicidal BehaviorBipolar Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

Patients currently suffering from a major depressive disorder, with ot without a history of suicidal event over the last 12 months, seen in consultation or hospitalization in the Psychiatric Emergencies and Post Acute Care of Montpellier Univeristy Hospital.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Blood sample

    Biological/Vaccine

    Blood sample for the determination of plasma lithium levels

Treatment groups

158 Participants
are divided into 2 treatment groups
Group A: Suicide attempters/ideations1 intervention
Group B: Affective controls1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline

Secondary outcomes

1

Basal plasma lithium levels

Basal plasma lithium levels (µeq/L) assessed in all participants at baseline.

Time frame
Baseline
2

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.

Time frame
Baseline
3

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.

Time frame
Baseline
4

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

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

Source ClinicalTrials.gov
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