Major Depressive DisorderLIPSNCT05409794
Basal Plasma Lithium Levels and Suicidal Events
An observational study of Major Depressive Disorder and Suicidal Behavior, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Suicidal Behavior, Bipolar Disorder
- What is being tested?
- Blood sample
- How many people
- 158 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2022to 9 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Montpellier
Montpellier
Benedicte NOBILE
About this study
Official 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.
Read the 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).
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 :
- an inverse association between lithium levels and suicidal events in patients
- 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.
- Being tested
- Blood sample
- Keywords
- Lithium, Depression, Suicide
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Depression, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Blood sample for the determination of plasma lithium levels
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (7)
Basal plasma lithium levels
Basal plasma lithium levels (µeq/L) assessed in all participants at baseline.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start9 Dec 2022
- Primary completion9 Jan 2026 (estimated)
- Study completion9 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409794
- Sponsor's protocol ID
- RECHMPL22_0039
- Acronym
- LIPS
- Status last verified
- Aug 2024
- First submitted
- 3 Jun 2022
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basal Plasma Lithium Levels and Suicidal Events (LIPS)
- ClinicalTrials.gov ID
- NCT05409794
- Acronym / sponsor ID
- LIPS / RECHMPL22_0039
- Keywords
- Lithium, Depression, Suicide
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 9 Jan 2026 (estimated)
- Study completion
- 9 Jan 2027 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 :
- an inverse association between lithium levels and suicidal events in patients
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suicide attempters/ideations | – | Biological: Blood samplePatients 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. |
| Affective controls | – | Biological: Blood samplePatients currently suffering from a major depressive disorder and reporting no suicidal event (suicide attempt or hospitalization for suicidal ideation) over the last 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleBlood sample for the determination of plasma lithium levels | Biological | Affective controls, Suicide attempters/ideations |
Primary outcome
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
7 secondary outcomes
Basal plasma lithium levels
Time frame: Baseline
Current suicidal ideation
Time frame: Baseline
Impulsiveness level
Time frame: Baseline
Aggression level
Time frame: Baseline
Bipolar disorder characteristics
Time frame: Baseline
Emotional lability
Time frame: Baseline
Suicide attempt characteristics
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Suicidal Behavior, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bénédicte NOBILE, Pharma D, PhD (+33467338581, b-nobile@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients rate with lithium levels above 0.1 µeq/L (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.