Brain Markers of Suicide Risk and Psychological Pain in Elderly Depressed Patients
SPAD-IRM
1 other identifier
observational
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2017
CompletedStudy Start
First participant enrolled
August 18, 2017
CompletedFirst Posted
Study publicly available on registry
September 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2019
CompletedMarch 9, 2020
March 1, 2020
2.3 years
April 21, 2017
March 6, 2020
Conditions
Keywords
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
Patient controls
depressed patients over 60 years of age without a personal history of suicide attempt scanned with MRI
Healthy Controls
Healthy subjects over 60 years, not depressed and without personal history of severe mental illness or suicide attempts, scanned with MRI
Interventions
Eligibility Criteria
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
Biospecimen
DNA, blood.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabrice Jollant, MD PhD
CHU Nîmes
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