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

NCT ID: NCT02847741

Last Updated: 2016-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 555 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2017-04-30

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)

Conditions

Current Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Major depressive episode

Depressive patients will be assessed by interview (psychiatrists), questionnaires and blood sampling, as the inpatients's routine care

Group Type: OTHER

patient's routine care

Intervention Type: OTHER

Interview by psychiatrists, questionnaires, blood analysis

Interventions

patient's routine care

Interview by psychiatrists, questionnaires, blood analysis

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Montpelleir University Hospital

Montpellier, , France

Countries

France

Other Identifiers

2011-A01657-34

Identifier Type: OTHER

Identifier Source: secondary_id

UF 8921

Identifier Type: -

Identifier Source: org_study_id