SPAD-IRM: Brain Markers of Suicide Risk and Psychological Pain in Elderly Depressed Patients

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Completed
CT.gov ID
NCT03287986
Collaborator
(none)
60
1
27.8
2.2

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: MRI

Study Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Brain Markers of Suicide Risk and Psychological Pain in Elderly Depressed Patients
Actual Study Start Date :
Aug 18, 2017
Actual Primary Completion Date :
Dec 13, 2019
Actual Study Completion Date :
Dec 13, 2019

Arms and Interventions

Arm Intervention/Treatment
Suicide attempters

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

Other: MRI
Structural and functional sequences

Patient controls

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

Other: MRI
Structural and functional sequences

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
Structural and functional sequences

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Brain structural volumes [Day 0]

    T1 sequence measured by MRI in each participant

  2. Brain structural connectivity [Day 0]

    Diffusion Tensor Imaging measured by MRI in each participant

  3. Brain functional connectivity [Day 0]

    Resting state activity measured by MRI in each participant

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Nimes Nîmes France 30029

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Fabrice Jollant, MD PhD, CHU Nîmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT03287986
Other Study ID Numbers:
  • LOCAL/2016/FJMW-01
First Posted:
Sep 19, 2017
Last Update Posted:
Mar 9, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Nīmes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2020