Brain Markers of Suicide Risk and Psychological Pain in Elderly Depressed Patients

Completed

• Conditions: Depressive Disorder; Suicide, Attempted

• Registration Number: NCT03287986
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The main objective of this study is to show MRI functional and structural differences between depressed elderly patients with a history of attempted suicide compared to depressed elderly patients with no history of attempted suicide and to elderly subjects with no personal history of depression or attempted suicide (healthy controls).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-21
• Study Start: 2017-08-18
• Study First Submitted QC: 2017-09-15
• Study First Posted: 2017-09-19
• Primary Completion: 2019-12-13
• Study Completion: 2019-12-13
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• The patient must have given their free and informed consent and signed the consent form
• be a member or beneficiary of a health insurance plan
• aged 60 years-old or more
• must be right-handed
• with a diagnosis of a current major depressive episode of moderate to severe severity according to diagnostic criteria.
• with or without a personal history of attempted suicide during life
• hospitalized or followed by a consultant in the department of Psychiatry of Nîmes University Hospital or in the Sophoras private clinic

Exclusion Criteria

• The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
• under safeguard of justice
• refuses to sign the consent
• It is impossible to give the subject informed information
• Current psychotic symptoms.
• Bipolar disorder.
• The subject presents an acute somatic decompensation incompatible with the realization of this study.
• The patient presents a mental confusion or a known Mini Mental State Examination score <24.
• Central neurological disease known in particular degenerative pathology, severe cranial trauma and severe cerebrovascular disease.
• Schizophrenia and other known psychotic disorders.
• Electroconvulsive therapy in the 12 months prior to study
• Inability to perform neuropsychological tests because of a language problem, poor understanding, a major tremor, inability to sit still, a major sight problem that cannot be corrected, or other severe cognitive impairment
• Contra-indication to magnetic resonance imaging (MRI): ferromagnetic implant in the body, piercing, claustrophobia, inability to remain elongated for 45 minutes.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain functional activity during unfairness	Day 0	Contrast in BOLD signal measured by 3T-Magnetic Resonance Imaging (MRI) during the fair vs unfair trials of the Ultimatum Game

Secondary Outcome Measures

Name	Time	Method
Brain structural volumes	Day 0	T1 sequence measured by MRI in each participant
Brain structural connectivity	Day 0	Diffusion Tensor Imaging measured by MRI in each participant
Brain functional connectivity	Day 0	Resting state activity measured by MRI in each participant
Correlation of MRI measures with psychological pain measures	Day 0	Psychological pain will be measured by the Visual Analog Scale (Olié et al. 2010) in each participant

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nîmes, France