Overview

This trial is active, not recruiting.

Condition current major depressive disorder
Treatment patient's routine care
Sponsor University Hospital, Montpellier
Start date June 2012
End date December 2016
Trial size 555 participants
Trial identifier NCT02847741, 2011-A01657-34, UF 8921

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Other)
Depressive patients will be assessed by interview (psychiatrists), questionnaires and blood sampling, as the inpatients's routine care
patient's routine care
Interview by psychiatrists, questionnaires, blood analysis

Primary Outcomes

Measure
frequency of suicide attempts
time frame: at 18 month

Secondary Outcomes

Measure
number of past SB
time frame: at 18 month
moral pain
time frame: at 18 month
physical pain
time frame: at 18 month
suicidal ideation
time frame: at 18 month
depression (Quick Inventory of Depressive Symptomatology)
time frame: at 18 month
history of childhood abuse
time frame: at 18 month
National Adult Reading Test score
time frame: at 18 month
scores to California Verbal Learning Test
time frame: at 18 month
scores to Iowa Gambling Task Time frame: 18 months
time frame: at 18 month
score to the brixton test
time frame: at 18 month
scores to verbal fluency
time frame: at 18 month
scores to Reversal Learning Task
time frame: at 18 month
scores to the Attentional Stroop test
time frame: at 18 month
relation between inflammatory markers and the occurrence of SB
time frame: at 18 month
relation between thyroid function and the occurrence of SB
time frame: at 18 month
relation between lipid profile and the occurrence of SB
time frame: at 18 month
relation between pharmacological assays and the occurrence of SB
time frame: at 18 month
relation between the characteristic of the mood depressive disorder (unipolar or bipolar depression) and the predictive or vulnerability factors of SB
time frame: at 18 month
the characteristic of past SB
time frame: at 18 month
moral pain
time frame: at 18 month
physical pain
time frame: at 18 month
suicidal ideation
time frame: at 18 month
depression level (Inventory of Depressive Symptomatology)
time frame: at 18 month
history of childhood abuse
time frame: at 18 month
National Adult Reading Test score ( NART)
time frame: at 18 month
scores to California Verbal Learning Test
time frame: at 18 month
scores to Iowa Gambling Task
time frame: at 18 month
score to the brixton test
time frame: at 18 month
verbal fluency
time frame: at 18 month
scores to Reversal Learning Task
time frame: at 18 month
scores to the Attentional Stroop test
time frame: at 18 month
relation between inflammatory markers and the response to antidepressant treatment
time frame: at 18 month
relation between thyroid function and the response to antidepressant treatment
time frame: at 18 month
relation between lipid profile and the response to antidepressant treatment
time frame: at 18 month
relation between pharmacological assays and the response to antidepressant treatment
time frame: at 18 month
lethality of past SB
time frame: at 18 month
Depression (Inventory of Depressive Symptomatology)
time frame: at 18 month
Depression (Beck Depression Inventory)
time frame: at 18 month
depression level (Beck depression Inventory)
time frame: at 18 month
depression level (Quick Inventory of Depressive Symptomatology)
time frame: at 18 month

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Predictive Nature of Total Cholesterol Threshold: Possible Link to Suicidal Behavior
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)
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University Hospital, Montpellier.