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

Current Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02847741
• Other study ID #: UF 8921
• Secondary ID: 2011-A01657-34
• Status: Active, not recruiting
• Phase: N/A
• First received: July 15, 2016
• Last updated: July 25, 2016
• Start date: June 2012
• Est. completion date: April 2017

Study information

• Verified date: July 2016
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 555
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Current Major Depressive Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Other:
• patient's routine care
Interview by psychiatrists, questionnaires, blood analysis

Locations

Country	Name	City	State
France	Montpelleir University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No