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Clinical Trials/NCT03287986
NCT03287986
Completed
Not Applicable

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

Centre Hospitalier Universitaire de Nīmes1 site in 1 country60 target enrollmentAugust 18, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depressive Disorder
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
60
Locations
1
Primary Endpoint
Brain functional activity during unfairness
Status
Completed
Last Updated
6 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
August 18, 2017
End Date
December 13, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

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 \<
  • Central neurological disease known in particular degenerative pathology, severe cranial trauma and severe cerebrovascular disease.
  • Schizophrenia and other known psychotic disorders.

Outcomes

Primary Outcomes

Brain functional activity during unfairness

Time Frame: Day 0

Contrast in BOLD signal measured by 3T-Magnetic Resonance Imaging (MRI) during the fair vs unfair trials of the Ultimatum Game

Secondary Outcomes

  • Brain functional connectivity(Day 0)
  • Correlation of MRI measures with psychological pain measures(Day 0)
  • Brain structural volumes(Day 0)
  • Brain structural connectivity(Day 0)

Study Sites (1)

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