Depressive Disorder, MajorSPADNCT02737540
Neuropsychological Factors Associated With Vulnerability to Suicidal Behavior in Depressed Elderly Patients
An observational study of Depressive Disorder, Major, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
The main objective of this study is to confirm the existence of risky decision making in a non strategic situation (Iowa Gambling Task) and a deficit of decision making in social situations, linked to greater sensitivity to injustice (Ultimatum Game) and a lower level of trust (Trust Game) in elderly depressed… 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, Major
- How many people
- 85 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Aug 2017to 30 Nov 2020
- 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: The study population consists of patients over 60 years of age with or without a personal history of suicide attempts, hospitalized in the Nîmes University Hospital psychiatry department or the Sophoras clinic for a major depressive episode. Healthy subjects over 60 years, not depressed and without personal history of severe mental illness or suicide attempts will also be recruited.
Who may be able to join
- The patient or his/her representative must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Patients with a diagnosis of current, moderate to severe, major depressive episode according to the DSM diagnostic criteria 5. This episode can be considered as part of a major depressive disorder or bipolar disorder.
- Patients with or without a personal history of suicide attempts. A suicide attempt is defined as any act performed with some intent to die (Mann 1998). Suicidal threats, aborted or interrupted gestures as well as self-mutilating acts without suicidal intent will not be considered as suicidal acts.
- Patients hospitalized (or followed as outpatients) in the Nîmes University Hospital psychiatry department or the Sophoras clinic in Nimes
- The subject or his/her representative must have given his/her informed and signed consent
- The subject must be insured or beneficiary of a health insurance plan
- Non-depressed subject without personal history of lifetime mood disorder or severe mental illness, or substance or alcohol abuse during the past 12 months
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection
- The patient (or his/her legal representative) refuses to sign the consent
- It is impossible to correctly inform the patient or his/her legal representative
- The patient has a known MMSE score <24 (elimination of probable dementia pathology)
Show all 28Show fewer
- Known central neurological disease including degenerative disease, severe head trauma and severe cerebral vascular disease
- Known schizophrenia and other psychotic disorders
- Alcohol or substance abuse in the last 12 months
- Electroconvulsive therapy in the 12 months preceding the study because of the risk of mnesic side effects
- Inability to perform neuropsychological tests because of a language problem, poor understanding, a major tremor, inability to sit still, a major sight problem that can not be corrected, or other severe cognitive impairment
- The subject presents an acute somatic decompensation incompatible with the completion of this study
- The patient has current confusion
- The subject is participating in another study
- The subject is in an exclusion period determined by a previous study
- The subject is under judicial protection
- The subject (or his/her legal representative) refuses to sign the consent
- It is impossible to correctly inform the subject or his/her legal representative
- The subject has a known MMSE score <24 (elimination of probable dementia pathology)
- Known central neurological disease including degenerative disease, severe head trauma and severe cerebral vascular disease
- Known schizophrenia and other psychotic disorders
- Alcohol or substance abuse in the last 12 months
- Electroconvulsive therapy in the 12 months preceding the study because of the risk of mnesic side effects
- Inability to perform neuropsychological tests because of a language problem, poor understanding, a major tremor, inability to sit still, a major sight problem that can not be corrected, or other severe cognitive impairment
- The subject has a mood disorder
- The subject presents an acute somatic decompensation incompatible with the completion of this study
- Thesubject has current confusion
- Pharmacological treatment is not a criterion for exclusion in itself but it will be left to the judgment of the evaluator to choose to include a subject or not (or to postpone inclusion) depending on the drug (eg. after weaning daytime sedative treatment and benzodiazepines).
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique Les Sophoras
Nîmes, 30000
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
The main objective of this study is to confirm the existence of risky decision making in a non strategic situation (Iowa Gambling Task) and a deficit of decision making in social situations, linked to greater sensitivity to injustice (Ultimatum Game) and a lower level of trust (Trust Game) in elderly depressed patients with a history of suicide attempts in comparison with older depressed patients without a history of suicidal acts and healthy subjects.
Read the detailed description
The secondary objectives are to confirm or explore the deficits of certain cognitive processes involved in potentially suicidal behavior in depressed elderly persons but that have been little or not studied to date. These include:
- cognitive control and sensitivity to interference (Victoria Stroop test, incompatibility test, flexibility test, Go / No-Go);
- Strategic recovery of semantic memory (verbal fluency test);
- Working memory (TEA);
- Insight related to depression (Mood Disorders Insight Scale);
- Recognition of facial emotions;
- Emotional regulation;
- Negative attitudes;
- Self-perception and;
- Time perspectives.
Finally, patients will be contacted by telephone at month 6 to assess the occurrence of a suicidal act during this period and thus calculate the predictive ability of cognitive and psychological factors.
- Conditions
- Depressive Disorder, Major
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Major depressive episode | This study population consists of patients over 60 years of age with or without a personal history of suicide attempts, hospitalized in the Nîmes University Hospital psychiatry department or the Sophoras clinic for a major depressive episode. | |
| Healthy subjects | Healthy subjects over 60 years, not depressed and without personal history of severe mental illness or suicide attempts will be recruited. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trust Game
Measured: Days 1-7
Ultimatum Game
Measured: Days 1-7
Iowa Gambling Task
Measured: Days 1-7
Secondary outcomes (14)
Stroop Victoria Test
Measured: Days 1-7
Incompatibility Test
Measured: Days 1-7
Flexibility test
Measured: Days 1-7
Go-NoGo
Measured: Days 1-7
Working memory - TEA
Measured: Days 1-7
Mood Disorders Insight Scale
Measured: Days 1-7
Verbal fluency test
Measured: Days 1-7
Future autobiographical fluency task
Measured: Days 1-7
Bristol Emotion Recognition Test
Measured: Days 1-7
Cognitive Emotion Regulation Questionnaire
Measured: Days 1-7
Questionnaire on negative attitudes towards problems
Measured: Days 1-7
Revised self-awareness scale, Self-reference task
Measured: Days 1-7
Balanced Temporal Perspective Scale
Measured: Days 1-7
Suicide attempt within 6 months of follow-up
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study start16 Aug 2017
- Primary completion1 Aug 2020
- Study completion30 Nov 2020
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies 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
- Prospective
- Enrolment
- 85 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, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737540
- Sponsor's protocol ID
- LOCAL/2016/MW-01
- Acronym
- SPAD
- Status last verified
- Jan 2021
- First submitted
- 8 Apr 2016
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Mann JJ. The neurobiology of suicide. Nat Med. 1998 Jan;4(1):25-30. doi: 10.1038/nm0198-025. No abstract available.
PubMed 9427602
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological Factors Associated With Vulnerability to Suicidal Behavior in Depressed Elderly Patients
- ClinicalTrials.gov ID
- NCT02737540
- Acronym / sponsor ID
- SPAD / LOCAL/2016/MW-01
- Conditions
- Depressive Disorder, Major
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 14 Apr 2016 (estimated)
- 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 confirm the existence of risky decision making in a non strategic situation (Iowa Gambling Task) and a deficit of decision making in social situations, linked to greater sensitivity to injustice (Ultimatum Game) and a lower level of trust (Trust Game) in elderly depressed patients with a history of suicide attempts in comparison with older depressed patients without a history of suicidal acts and healthy subjects.
Detailed description
The secondary objectives are to confirm or explore the deficits of certain cognitive processes involved in potentially suicidal behavior in depressed elderly persons but that have been little or not studied to date. These include:
- cognitive control and sensitivity to interference (Victoria Stroop test, incompatibility test, flexibility test, Go / No-Go);
- Strategic recovery of semantic memory (verbal fluency test);
- Working memory (TEA);
- Insight related to depression (Mood Disorders Insight Scale);
- Recognition of facial emotions;
- Emotional regulation;
- Negative attitudes;
- Self-perception and;
- Time perspectives.
Finally, patients will be contacted by telephone at month 6 to assess the occurrence of a suicidal act during this period and thus calculate the predictive ability of cognitive and psychological factors.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Major depressive episode | – | –This study population consists of patients over 60 years of age with or without a personal history of suicide attempts, hospitalized in the Nîmes University Hospital psychiatry department or the Sophoras clinic for a major depressive episode. |
| Healthy subjects | – | –Healthy subjects over 60 years, not depressed and without personal history of severe mental illness or suicide attempts will be recruited. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients over 60 years of age with or without a personal history of suicide attempts, hospitalized in the Nîmes University Hospital psychiatry department or the Sophoras clinic for a major depressive episode. Healthy subjects over 60 years, not depressed and without personal history of severe mental illness or suicide attempts will also be recruited.
Key inclusion criteria (8 listed)
- The patient or his/her representative must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Patients with a diagnosis of current, moderate to severe, major depressive episode according to the DSM diagnostic criteria 5. This episode can be considered as part of a major depressive disorder or bipolar disorder.
- Patients with or without a personal history of suicide attempts. A suicide attempt is defined as any act performed with some intent to die (Mann 1998). Suicidal threats, aborted or interrupted gestures as well as self-mutilating acts without suicidal intent will not be considered as suicidal acts.
- Patients hospitalized (or followed as outpatients) in the Nîmes University Hospital psychiatry department or the Sophoras clinic in Nimes
Key exclusion criteria (28 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection
- The patient (or his/her legal representative) refuses to sign the consent
- It is impossible to correctly inform the patient or his/her legal representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Trust Game
Time frame: Days 1-7
Ultimatum Game
Time frame: Days 1-7
Iowa Gambling Task
Time frame: Days 1-7
14 secondary outcomes
Stroop Victoria Test
Time frame: Days 1-7
Incompatibility Test
Time frame: Days 1-7
Flexibility test
Time frame: Days 1-7
Go-NoGo
Time frame: Days 1-7
Working memory - TEA
Time frame: Days 1-7
Mood Disorders Insight Scale
Time frame: Days 1-7
Verbal fluency test
Time frame: Days 1-7
Future autobiographical fluency task
Time frame: Days 1-7
Bristol Emotion Recognition Test
Time frame: Days 1-7
Cognitive Emotion Regulation Questionnaire
Time frame: Days 1-7
Questionnaire on negative attitudes towards problems
Time frame: Days 1-7
Revised self-awareness scale, Self-reference task
Time frame: Days 1-7
Balanced Temporal Perspective Scale
Time frame: Days 1-7
Suicide attempt within 6 months of follow-up
Time frame: Month 6
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Background: PubMed 9427602Mann JJ. The neurobiology of suicide. Nat Med. 1998 Jan;4(1):25-30. doi: 10.1038/nm0198-025. No abstract available.
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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 study director
Centre Hospitalier Universitaire de Nīmes
2 sites 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, Major, run by Centre Hospitalier Universitaire de Nīmes at 2 sites 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 8 inclusion and 28 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: stopped early, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
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?
Trust Game (time frame: Days 1-7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02737540, which also lists 1 linked publication.
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 1 Feb 2021.