Predictive Nature of Total Cholesterol Threshold: Possible Link to Suicidal Behavior

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.

Study Overview

• Status: Unknown
• Conditions: Current Major Depressive Disorder
• Intervention / Treatment: Other: patient's routine care

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)

• Study Type: Interventional
• Enrollment (Actual): 555
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Montpelleir University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Major depressive episode; Depressive patients will be assessed by interview (psychiatrists), questionnaires and blood sampling, as the inpatients's routine care	Other: patient's routine care; Interview by psychiatrists, questionnaires, blood analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of suicide attempts	frequency of suicide attempts during the 18months follow-up, according to the total cholesterol threshold at baseline. The biological sampling is carried out after 12 hours of fasting.	at 18 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of past SB	Studying the relation between the number of past SB (assessed by the Columbia Suicide History Form) and the occurrence of new SB during the 18 months follow-up	at 18 month
moral pain	Studying the relation between moral pain (assessed by Likert scale from 0 to 10) at baseline and the occurrence of new SB during the 18 months follow-up	at 18 month
physical pain	Studying the relation between physical pain (assessed Likert scale from 0 to 10) at baseline and the occurrence of new SB during the 18 months follow-up	at 18 month
suicidal ideation	Studying the relation between suicidal ideation (assessed by the Columbia Suicide Severity Rating Scale, the Scale of Suicidal Ideation) and the occurrence of new SB during the 18 months follow-up	at 18 month
depression (Quick Inventory of Depressive Symptomatology)	Studying the relation between score to the Quick Inventory of Depressive Symptomatology and the occurrence of new SB during the 18 months follow-up	at 18 month
history of childhood abuse	Studying the relation between an history of childhood abuse (assessed by the Childhood Trauma Questionnaire) and the occurrence of new SB during the 18 months follow-up	at 18 month
National Adult Reading Test score	Studying the relation between NART score (assessment of intellectual level) and the occurrence of new SB during the 18 months follow-up	at 18 month
scores to California Verbal Learning Test	Studying the relation between scores to California Verbal Learning Test (assessment of verbal memory) and the occurrence of SB during the 18 months follow-up	at 18 month
scores to Iowa Gambling Task Time frame: 18 months	Studying the relation between scores to the Iowa Gambling Task (assessment of decision making) and the occurrence of new SB during the 18 months follow-up	at 18 month
score to the brixton test	Studying the relation between score to the brixton test (assessment of mental flexibility) and the occurrence of SB during the 18 months follow-up	at 18 month
scores to verbal fluency	Studying the relation between scores to verbal fluency and the occurrence of SB during the 18 months follow-up	at 18 month
scores to Reversal Learning Task	Studying the relation between scores to Reversal learning task (assessment of decision making) and the occurrence of new SB during the 18 months follow-up	at 18 month
scores to the Attentional Stroop test	Studying the relation between scores to Attentional Stroop test and the occurrence of new SB during the 18 months follow-up	at 18 month
relation between inflammatory markers and the occurrence of SB	Studying the relation between inflammatory markers at baseline and the occurrence of new SB during the 18 months follow-	at 18 month
relation between thyroid function and the occurrence of SB	Studying the relation between thyroid function at baseline and the occurrence of new SB during the 18 months follow-up	at 18 month
relation between lipid profile and the occurrence of SB	Studying the relation between lipid profile at baseline and the occurrence of new SB during the 18 months follow-up	at 18 month
relation between pharmacological assays and the occurrence of SB	Studying the relation between pharmacological assays at baseline and the occurrence of new SB during the 18 months follow-up	at 18 month
relation between the characteristic of the mood depressive disorder (unipolar or bipolar depression) and the predictive or vulnerability factors of SB	Studying the potential specificity of predictive or vulnerability factors of SB depending on whether the diagnosis is unipolar or bipolar depression	at 18 month
the characteristic of past SB	Studying the relation between the number and the lethality of past SB (assessed by the Columbia Suicide History Form, the Risk Rescue Rating Scale, the Suicidal Intent Scale ) and the response to antidepressant treatment during the 18 months follow-up	at 18 month
moral pain	Studying the relation between moral pain (assessed by Likert scale from 0 to 10) at baseline and the response to antidepressant treatment during the 18 months follow-up	at 18 month
physical pain	Studying the relation between physical pain (assessed by Likert scale from 0 to 10) at baseline and the response to antidepressant treatment during the 18 months follow-up	at 18 month
suicidal ideation	Studying the relation between suicidal ideation (assessed by the Columbia Suicide Severity Rating Scale, the Scale of Suicidal Ideation) and the response to antidepressant treatment during the 18 months follow-up	at 18 month
depression level (Inventory of Depressive Symptomatology)	Studying the relation between score to the Inventory Of Depressive Symptomatology and the response to antidepressant treatment during the 18 months follow-up	at 18 month
history of childhood abuse	Studying the relation between an history of childhood abuse (assessed by the childhood trauma questionnaire) and the response to antidepressant treatment during the 18 months follow-up	at 18 month
National Adult Reading Test score ( NART)	Studying the relation between NART score (assessment of intellectual level ) and the response to antidepressant treatment during the 18 months follow-up	at 18 month
scores to California Verbal Learning Test	Studying the relation between scores to California Verbal Learning Test (assessment of verbal memory) and the response to antidepressant treatment during the 18 months follow-up	at 18 month
scores to Iowa Gambling Task	Studying the relation between scores to Iowa Gambling Task (assessment of decision making) and the response to antidepressant treatment during the 18 months follow-up	at 18 month
score to the brixton test	Studying the relation between score to the brixton test (assessment of mental flexibility) and the response to antidepressant treatment during the 18 months follow-up	at 18 month
verbal fluency	Studying the relation between score to verbal fluency and the response to antidepressant treatment during the 18 months follow-up	at 18 month
scores to Reversal Learning Task	Studying the relation between scores to Reversal learning task (assessment of decision making) and the response to antidepressant treatment during the 18 months follow-up	at 18 month
scores to the Attentional Stroop test	Studying the relation between scores to Attentional Stroop test and the response to antidepressant treatment during the 18 months follow-up	at 18 month
relation between inflammatory markers and the response to antidepressant treatment	Studying the relation between inflammatory markers at baseline and the response to antidepressant treatment during the 18 months follow-up	at 18 month
relation between thyroid function and the response to antidepressant treatment	Studying the relation between thyroid function at baseline and the response to antidepressant treatment during the 18 months follow-up	at 18 month
relation between lipid profile and the response to antidepressant treatment	Studying the relation between lipid profile at baseline and the response to antidepressant treatment during the 18 months follow-up	at 18 month
relation between pharmacological assays and the response to antidepressant treatment	Studying the relation between pharmacological assays at baseline and t the response to antidepressant treatment during the 18 months follow-up	at 18 month
lethality of past SB	Studying the relation between the lethality of past SB (assessed by the Columbia Suicide History Form) and the occurrence of new SB during the 18 months follow-up	at 18 month
Depression (Inventory of Depressive Symptomatology)	Studying the relation between score to the Inventory Of Depressive Symptomatology and the occurrence of new SB during the 18 months follow-up	at 18 month
Depression (Beck Depression Inventory)	Studying the relation between score to the Beck Depression Inventory and the occurrence of new SB during the 18 months follow-up	at 18 month
depression level (Beck depression Inventory)	Studying the relation between score to the Beck depression Inventory and the response to antidepressant treatment during the 18 months follow-up	at 18 month
depression level (Quick Inventory of Depressive Symptomatology)	Studying the relation between score to the Quick Inventory of Depressive Symptomatology and the response to antidepressant treatment during the 18 months follow-up	at 18 month

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): April 1, 2017

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimate): July 28, 2016

Study Record Updates

• Last Update Posted (Estimate): July 28, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Depression; Cholesterol; Suicidal behavior; Predictive factor
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: UF 8921; 2011-A01657-34 (Other Identifier: Agence Nationale de Sécurité des Médicaments)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO