Depressive DisorderSPAD-IRMNCT03287986
Brain Markers of Suicide Risk and Psychological Pain in Elderly Depressed Patients
An observational study of Depressive Disorder and Suicide, Attempted, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Suicide, Attempted
- What is being tested?
- MRI
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 18 Aug 2017to 13 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Elderly depressed patients
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Depressive Disorder, Suicide, Attempted
- Being tested
- MRI
- Keywords
- Elderly, MRI
- Medical subject headings
- Depressive Disorder, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Structural and functional sequences
| Study group | Role | What they receive |
|---|---|---|
| Suicide attempters | Depressed patients over 60 years of age with a personal history of suicide attempts scanned with MRI Receives: Other: MRI | |
| Patient controls | depressed patients over 60 years of age without a personal history of suicide attempt scanned with MRI Receives: 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 Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Secondary outcomes (4)
Brain structural volumes
T1 sequence measured by MRI in each participant
Measured: Day 0
Brain structural connectivity
Diffusion Tensor Imaging measured by MRI in each participant
Measured: Day 0
Brain functional connectivity
Resting state activity measured by MRI in each participant
Measured: Day 0
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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start18 Aug 2017
- Primary completion13 Dec 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice Jollant, MD PhD, Principal investigator, CHU Nîmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287986
- Sponsor's protocol ID
- LOCAL/2016/FJMW-01
- Acronym
- SPAD-IRM
- Status last verified
- Mar 2020
- First submitted
- 21 Apr 2017
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Markers of Suicide Risk and Psychological Pain in Elderly Depressed Patients
- ClinicalTrials.gov ID
- NCT03287986
- Acronym / sponsor ID
- SPAD-IRM / LOCAL/2016/FJMW-01
- Conditions
- Depressive Disorder, Suicide, Attempted
- Keywords
- Elderly, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 19 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suicide attempters | – | Other: MRIDepressed patients over 60 years of age with a personal history of suicide attempts scanned with MRI |
| Patient controls | – | Other: MRIdepressed patients over 60 years of age without a personal history of suicide attempt scanned with MRI |
| Healthy Controls | – | Other: MRIHealthy subjects over 60 years, not depressed and without personal history of severe mental illness or suicide attempts, scanned with MRI |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly depressed patients
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIStructural and functional sequences | Other | Healthy Controls, Patient controls, Suicide attempters |
Primary outcome
Brain functional activity during unfairness
Time frame: Day 0
Contrast in BOLD signal measured by 3T-Magnetic Resonance Imaging (MRI) during the fair vs unfair trials of the Ultimatum Game
4 secondary outcomes
Brain structural volumes
Time frame: Day 0
Brain structural connectivity
Time frame: Day 0
Brain functional connectivity
Time frame: Day 0
Correlation of MRI measures with psychological pain measures
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice Jollant, MD PhD principal investigator
CHU Nîmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder and Suicide, Attempted, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain functional activity during unfairness (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.