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CompletedNCT03287986SPAD-IRMUpdated Mar 9, 2020

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

An observational study in Depressive Disorder and Suicide, Attempted, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-09.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
60
Ages
60 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Depressive Disorder
  • Suicide, Attempted

Keywords

  • Elderly
  • MRI
03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Elderly depressed patients

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

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.
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
60 participants (actual)
Patient registry
No
Biospecimen retention
None retained

Groups and cohorts

  • Suicide attempters

    Depressed patients over 60 years of age with a personal history of suicide attempts scanned with MRI

    Other: MRI

  • Patient controls

    depressed patients over 60 years of age without a personal history of suicide attempt scanned with MRI

    Other: MRI

  • Healthy Controls

    Healthy subjects over 60 years, not depressed and without personal history of severe mental illness or suicide attempts, scanned with MRI

    Other: MRI

Interventions

  • OtherMRI

    Structural and functional sequences

05

What researchers measure

Primary outcomes

  1. Brain functional activity during unfairness

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

    Time frame: Day 0

Secondary outcomes

  1. Brain structural volumes

    T1 sequence measured by MRI in each participant

    Time frame: Day 0

  2. Brain structural connectivity

    Diffusion Tensor Imaging measured by MRI in each participant

    Time frame: Day 0

  3. Brain functional connectivity

    Resting state activity measured by MRI in each participant

    Time frame: Day 0

  4. Correlation of MRI measures with psychological pain measures

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

    Time frame: Day 0

06

Study locations

1 site
  • CHU Nimes
    Nîmes, 30029, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03287986
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Sep 19, 2017
Start date
Aug 18, 2017
Primary completion
Dec 13, 2019
Completion
Dec 13, 2019
Last update
Mar 9, 2020

Study contacts

Fabrice Jollant, MD PhD
principal investigator · CHU Nîmes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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