Skip to main content
OpenTrials
Completed

NCT Number: NCT03287986

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI

Other

Structural and functional sequences

Primary outcomes

  1. 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

  1. Brain structural volumes

    Time frame: Day 0

    T1 sequence measured by MRI in each participant

  2. Brain structural connectivity

    Time frame: Day 0

    Diffusion Tensor Imaging measured by MRI in each participant

  3. Brain functional connectivity

    Time frame: Day 0

    Resting state activity measured by MRI in each participant

  4. Correlation of MRI measures with psychological pain measures

    Time frame: Day 0

    Psychological pain will be measured by the Visual Analog Scale (Olié et al. 2010) in each participant

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: SPAD-IRM

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 19, 2017
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.