Clinical trial NCT02847741: Predictive Nature of Total Cholesterol Threshold: Possible Link to Suicidal Behavior
Official title: Predictive Nature of Total Cholesterol Threshold: Possible Link to Suicidal Behavior
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Current Major Depressive Disorder
Keywords: Depression
Cholesterol
Suicidal behavior
Predictive factor
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 555
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Suicidal behavior (SB) is a public health problem. The clinical model currently admitted to the understanding of SB is a stress vulnerability model, but so far, all scientific works has no clinical application. The management of psychiatric patients, including depressed subjects, faces the inability to detect those with a high risk of SB. Many studies have shown a link between low cholesterol and SB. A study has recently proposed a total cholesterol threshold below which the risk of suicide could be increased. However, a prospective study is needed to assess the predictive nature of such an indicator.

Detailed description: Investigators propose to assess, within a cohort of patients, the predictive value of a total cholesterol threshold in the occurrence of SB.

555 inpatients suffering from a current Major depressive disorder (MDD), hospitalized in the Department of Emergency Psychiatry and Post Acute Care will be recruited.

Each patient will attend a total of 5 visits during a follow-up period of 18 months (visits at 1, 3, 6, 12, and 18 months)

Eligibility criteria: Inclusion criteria:

* Major
* Meet the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM) criteria for a major depressive episode
* Subject who signed the non-opposition form
* Able to understand the nature, purpose and methodology of the study
* Able to understand and perform the clinical and neuropsychological evaluations.

Exclusion criteria:

* Subject whose primary psychiatric diagnosis is not a major depressive episode according to DSM-IV criteria (the existence of psychiatric comorbidity is not a criterion for non-inclusion)
* Refusal of participation
* Subject Deprived of liberty (by judicial or administrative decision)
* Subject protected by law (guardianship)
* Subject exclusion period in relation to another protocol
* Subject for which the maximum annual amount of allowances of € 4,500 has been reached
* Subject not affiliated to a social security scheme or not being the beneficiary of such a scheme.

Primary outcomes:
measure: frequency of suicide attempts
timeFrame: at 18 month
Secondary outcomes:
measure: number of past SB
timeFrame: at 18 month
measure: moral pain
timeFrame: at 18 month
measure: physical pain
timeFrame: at 18 month
measure: suicidal ideation
timeFrame: at 18 month
measure: depression (Quick Inventory of Depressive Symptomatology)
timeFrame: at 18 month
measure: history of childhood abuse
timeFrame: at 18 month
measure: National Adult Reading Test score
timeFrame: at 18 month
measure: scores to California Verbal Learning Test
timeFrame: at 18 month
measure: scores to Iowa Gambling Task Time frame: 18 months
timeFrame: at 18 month
measure: score to the brixton test
timeFrame: at 18 month
measure: scores to verbal fluency
timeFrame: at 18 month
measure: scores to Reversal Learning Task
timeFrame: at 18 month
measure: scores to the Attentional Stroop test
timeFrame: at 18 month
measure: relation between inflammatory markers and the occurrence of SB
timeFrame: at 18 month
measure: relation between thyroid function and the occurrence of SB
timeFrame: at 18 month
measure: relation between lipid profile and the occurrence of SB
timeFrame: at 18 month
measure: relation between pharmacological assays and the occurrence of SB
timeFrame: at 18 month
measure: relation between the characteristic of the mood depressive disorder (unipolar or bipolar depression) and the predictive or vulnerability factors of SB
timeFrame: at 18 month
measure: the characteristic of past SB
timeFrame: at 18 month
measure: moral pain
timeFrame: at 18 month
measure: physical pain
timeFrame: at 18 month
measure: suicidal ideation
timeFrame: at 18 month
measure: depression level (Inventory of Depressive Symptomatology)
timeFrame: at 18 month
measure: history of childhood abuse
timeFrame: at 18 month
measure: National Adult Reading Test score ( NART)
timeFrame: at 18 month
measure: scores to California Verbal Learning Test
timeFrame: at 18 month
measure: scores to Iowa Gambling Task
timeFrame: at 18 month
measure: score to the brixton test
timeFrame: at 18 month
measure: verbal fluency
timeFrame: at 18 month
measure: scores to Reversal Learning Task
timeFrame: at 18 month
measure: scores to the Attentional Stroop test
timeFrame: at 18 month
measure: relation between inflammatory markers and the response to antidepressant treatment
timeFrame: at 18 month
measure: relation between thyroid function and the response to antidepressant treatment
timeFrame: at 18 month
measure: relation between lipid profile and the response to antidepressant treatment
timeFrame: at 18 month
measure: relation between pharmacological assays and the response to antidepressant treatment
timeFrame: at 18 month
measure: lethality of past SB
timeFrame: at 18 month
measure: Depression (Inventory of Depressive Symptomatology)
timeFrame: at 18 month
measure: Depression (Beck Depression Inventory)
timeFrame: at 18 month
measure: depression level (Beck depression Inventory)
timeFrame: at 18 month
measure: depression level (Quick Inventory of Depressive Symptomatology)
timeFrame: at 18 month
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpelleir University Hospital
Study officials:
References: