Clinical trial NCT03287986: Brain Markers of Suicide Risk and Psychological Pain in Elderly Depressed Patients
Official title: Brain Markers of Suicide Risk and Psychological Pain in Elderly Depressed Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder
Suicide, Attempted
Keywords: Elderly
MRI
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly depressed patients

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Brain functional activity during unfairness
timeFrame: Day 0
Secondary outcomes:
measure: Brain structural volumes
timeFrame: Day 0
measure: Brain structural connectivity
timeFrame: Day 0
measure: Brain functional connectivity
timeFrame: Day 0
measure: Correlation of MRI measures with psychological pain measures
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nîmes
name: Fabrice Jollant, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: