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

Depressive Disorder Clinical Trial

— SPAD-IRM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03287986
• Other study ID #: LOCAL/2016/FJMW-01
• Status: Completed
• Start date: August 18, 2017
• Est. completion date: December 13, 2019

Study information

• Verified date: March 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 13, 2019
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder
• Suicide
• Suicide, Attempted

Intervention

Other:
• MRI
Structural and functional sequences

Locations

Country	Name	City	State
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Brain structural volumes	T1 sequence measured by MRI in each participant	Day 0
Secondary	Brain structural connectivity	Diffusion Tensor Imaging measured by MRI in each participant	Day 0
Secondary	Brain functional connectivity	Resting state activity measured by MRI in each participant	Day 0
Secondary	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	Day 0