NCT03287986

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

August 18, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2019

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

2.3 years

First QC Date

April 21, 2017

Last Update Submit

March 6, 2020

Conditions

Keywords

ElderlyMRI

Outcome Measures

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

    Day 0

Secondary Outcomes (4)

  • Brain structural volumes

    Day 0

  • Brain structural connectivity

    Day 0

  • Brain functional connectivity

    Day 0

  • Correlation of MRI measures with psychological pain measures

    Day 0

Study Arms (3)

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

MRIOTHER

Structural and functional sequences

Healthy ControlsPatient controlsSuicide attempters

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly depressed patients

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

Biospecimen

Retention: NONE RETAINED

DNA, blood.

MeSH Terms

Conditions

Depressive DisorderSuicide, Attempted

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersSuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Fabrice Jollant, MD PhD

    CHU Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2017

First Posted

September 19, 2017

Study Start

August 18, 2017

Primary Completion

December 13, 2019

Study Completion

December 13, 2019

Last Updated

March 9, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations