Basal Plasma Lithium Levels and Suicidal Events

NCT05409794 | Recruiting

• 1 other identifier: RECHMPL22_0039
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Suicidal Behavior; Bipolar Disorder

Keywords

Lithium; Depression; Suicide

Outcome Measures

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

  Baseline

Secondary Outcomes (7)

• Basal plasma lithium levels

  Baseline

• Current suicidal ideation

  Baseline

• Impulsiveness level

  Baseline

• Aggression level

  Baseline

• Bipolar disorder characteristics

  Baseline

Study Arms (2)

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.

Biological: Blood sample

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.

Biological: Blood sample

Interventions

Blood sample BIOLOGICAL

Blood sample for the determination of plasma lithium levels

Affective controls; Suicide attempters/ideations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, France

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Depression; Suicide

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Behavioral Symptoms; Behavior; Self-Injurious Behavior

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Bénédicte NOBILE, Pharma D, PhD

CONTACT

+33467338581; b-nobile@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 8, 2022
• Study Start: December 9, 2022
• Primary Completion: January 9, 2026
• Study Completion (Estimated): January 9, 2027
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

FR (1)