Predictors of Suicidal Behavior in Depression (SECS)
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|ClinicalTrials.gov Identifier: NCT02904005|
Recruitment Status : Unknown
Verified July 2016 by University Hospital, Montpellier.
Recruitment status was: Recruiting
First Posted : September 16, 2016
Last Update Posted : September 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Suicidal Behavior Depression Traumatic Events Impulsivity Aggression||Other: Standardized assessment on depressed patients||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||National Multicentric Study on the Predictive Factors for Suicidal Behavior During a Major Depressive Episode|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
Depressed patients with a recent suicide attempt or without any personal history of suicide attempt
Other: Standardized assessment on depressed patients
At inclusion, socio-demographic characteristics, main life events, psychopathology (comorbidity, personality dimensions, characterisation of SB) and biological sample will be performed by psychiatrist and nurse. Investigators will retrieve the results of biological assays routinely made as part of standard collect biological results routinely done for all depressed patient.
At follow-up (3 months, 6 months, 12 months), they will assess thymic state, occurrence of suicidal ideation and suicide attempt and environmental stressors. In case of non response, the general physician or the psychiatrist in charge of the patient will be contacted to assess the occurrence of SB during the year. In case of death or absence of clinical information, a request for cause of death certificate will be carried out through tne National Institute of Health and Medical research (INSERM) Unit 1018 / Epidemiological center on medical causes of death (CépiDc).
- Suicide attempt during follow-up [ Time Frame: At one year ]Evaluation of the occurrence of a suicide attempt by the Columbia-Suicide Severity Rating Scale (C-SSRS )
- Depressive level [ Time Frame: At 3, 6 and 12 months after the inclusion ]Measured by clinician with Inventory of Depressive Symptomotology (IDS-C 30)
- Depressive level [ Time Frame: At 3, 6 and 12 months after the inclusion ]Measured with a self questionnaire Quick Inventory of Depressive Symptomatology (QIDS-RS)
- Anxiety [ Time Frame: At 3, 6 and 12 months after the inclusion ]Measured with a self questionnaire the State-Trait Anxiety Inventory (STAI)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02904005
|Contact: Emilie OLIE, MD PhD||+33 4 67 33 82 firstname.lastname@example.org|
|Montpellier University Hospital||Recruiting|
|Montpellier, France, 34295|
|Contact: GENTY Catherine, MD +33 4 67 99 61 45 75 email@example.com|