Current Major Depressive DisorderNCT02847741
Predictive Nature of Total Cholesterol Threshold: Possible Link to Suicidal Behavior
A study testing patient's routine care in people with Current Major Depressive Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Suicidal behavior (SB) is a public health problem. The clinical model currently admitted to the understanding of SB is a stress vulnerability model, but so far, all scientific works has no clinical application. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Current Major Depressive Disorder
- What is being tested?
- patient's routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 555 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Apr 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major
- Meet the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM) criteria for a major depressive episode
- Subject who signed the non-opposition form
- Able to understand the nature, purpose and methodology of the study
- Able to understand and perform the clinical and neuropsychological evaluations.
Who cannot join
- Subject whose primary psychiatric diagnosis is not a major depressive episode according to DSM-IV criteria (the existence of psychiatric comorbidity is not a criterion for non-inclusion)
- Refusal of participation
- Subject Deprived of liberty (by judicial or administrative decision)
- Subject protected by law (guardianship)
- Subject exclusion period in relation to another protocol
- Subject for which the maximum annual amount of allowances of € 4,500 has been reached
- Subject not affiliated to a social security scheme or not being the beneficiary of such a scheme.
Trial locations and contacts
1 site in 1 country.
About this study
Suicidal behavior (SB) is a public health problem. The clinical model currently admitted to the understanding of SB is a stress vulnerability model, but so far, all scientific works has no clinical application. The management of psychiatric patients, including depressed subjects, faces the inability to detect those with a high risk of SB. Many studies have shown a link between low cholesterol and SB. A study has recently proposed a total cholesterol threshold below which the risk of suicide could be increased. However, a prospective study is needed to assess the predictive nature of such an indicator.
Read the detailed description
Investigators propose to assess, within a cohort of patients, the predictive value of a total cholesterol threshold in the occurrence of SB.
555 inpatients suffering from a current Major depressive disorder (MDD), hospitalized in the Department of Emergency Psychiatry and Post Acute Care will be recruited.
Each patient will attend a total of 5 visits during a follow-up period of 18 months (visits at 1, 3, 6, 12, and 18 months)
- Conditions
- Current Major Depressive Disorder
- Being tested
- patient's routine care
- Keywords
- Depression, Cholesterol, Suicidal behavior, Predictive factor
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient's routine careOther
Interview by psychiatrists, questionnaires, blood analysis
| Study group | Role | What they receive |
|---|---|---|
| Major depressive episode | Other | Depressive patients will be assessed by interview (psychiatrists), questionnaires and blood sampling, as the inpatients's routine care Receives: Other: patient's routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of suicide attempts
frequency of suicide attempts during the 18months follow-up, according to the total cholesterol threshold at baseline. The biological sampling is carried out after 12 hours of fasting.
Measured: at 18 month
Secondary outcomes (40)
number of past SB
Studying the relation between the number of past SB (assessed by the Columbia Suicide History Form) and the occurrence of new SB during the 18 months follow-up
Measured: at 18 month
moral pain
Studying the relation between moral pain (assessed by Likert scale from 0 to 10) at baseline and the occurrence of new SB during the 18 months follow-up
Measured: at 18 month
physical pain
Studying the relation between physical pain (assessed Likert scale from 0 to 10) at baseline and the occurrence of new SB during the 18 months follow-up
Measured: at 18 month
suicidal ideation
Studying the relation between suicidal ideation (assessed by the Columbia Suicide Severity Rating Scale, the Scale of Suicidal Ideation) and the occurrence of new SB during the 18 months follow-up
Measured: at 18 month
depression (Quick Inventory of Depressive Symptomatology)
Studying the relation between score to the Quick Inventory of Depressive Symptomatology and the occurrence of new SB during the 18 months follow-up
Measured: at 18 month
history of childhood abuse
Studying the relation between an history of childhood abuse (assessed by the Childhood Trauma Questionnaire) and the occurrence of new SB during the 18 months follow-up
Measured: at 18 month
National Adult Reading Test score
Studying the relation between NART score (assessment of intellectual level) and the occurrence of new SB during the 18 months follow-up
Measured: at 18 month
scores to California Verbal Learning Test
Studying the relation between scores to California Verbal Learning Test (assessment of verbal memory) and the occurrence of SB during the 18 months follow-up
Measured: at 18 month
scores to Iowa Gambling Task Time frame: 18 months
Studying the relation between scores to the Iowa Gambling Task (assessment of decision making) and the occurrence of new SB during the 18 months follow-up
Measured: at 18 month
score to the brixton test
Studying the relation between score to the brixton test (assessment of mental flexibility) and the occurrence of SB during the 18 months follow-up
Measured: at 18 month
scores to verbal fluency
Studying the relation between scores to verbal fluency and the occurrence of SB during the 18 months follow-up
Measured: at 18 month
scores to Reversal Learning Task
Studying the relation between scores to Reversal learning task (assessment of decision making) and the occurrence of new SB during the 18 months follow-up
Measured: at 18 month
scores to the Attentional Stroop test
Studying the relation between scores to Attentional Stroop test and the occurrence of new SB during the 18 months follow-up
Measured: at 18 month
relation between inflammatory markers and the occurrence of SB
Studying the relation between inflammatory markers at baseline and the occurrence of new SB during the 18 months follow-
Measured: at 18 month
relation between thyroid function and the occurrence of SB
Studying the relation between thyroid function at baseline and the occurrence of new SB during the 18 months follow-up
Measured: at 18 month
relation between lipid profile and the occurrence of SB
Studying the relation between lipid profile at baseline and the occurrence of new SB during the 18 months follow-up
Measured: at 18 month
relation between pharmacological assays and the occurrence of SB
Studying the relation between pharmacological assays at baseline and the occurrence of new SB during the 18 months follow-up
Measured: at 18 month
relation between the characteristic of the mood depressive disorder (unipolar or bipolar depression) and the predictive or vulnerability factors of SB
Studying the potential specificity of predictive or vulnerability factors of SB depending on whether the diagnosis is unipolar or bipolar depression
Measured: at 18 month
the characteristic of past SB
Studying the relation between the number and the lethality of past SB (assessed by the Columbia Suicide History Form, the Risk Rescue Rating Scale, the Suicidal Intent Scale ) and the response to antidepressant treatment during the 18 months follow-up
Measured: at 18 month
moral pain
Studying the relation between moral pain (assessed by Likert scale from 0 to 10) at baseline and the response to antidepressant treatment during the 18 months follow-up
Measured: at 18 month
physical pain
Studying the relation between physical pain (assessed by Likert scale from 0 to 10) at baseline and the response to antidepressant treatment during the 18 months follow-up
Measured: at 18 month
suicidal ideation
Studying the relation between suicidal ideation (assessed by the Columbia Suicide Severity Rating Scale, the Scale of Suicidal Ideation) and the response to antidepressant treatment during the 18 months follow-up
Measured: at 18 month
depression level (Inventory of Depressive Symptomatology)
Studying the relation between score to the Inventory Of Depressive Symptomatology and the response to antidepressant treatment during the 18 months follow-up
Measured: at 18 month
history of childhood abuse
Studying the relation between an history of childhood abuse (assessed by the childhood trauma questionnaire) and the response to antidepressant treatment during the 18 months follow-up
Measured: at 18 month
National Adult Reading Test score ( NART)
Studying the relation between NART score (assessment of intellectual level ) and the response to antidepressant treatment during the 18 months follow-up
Measured: at 18 month
scores to California Verbal Learning Test
Studying the relation between scores to California Verbal Learning Test (assessment of verbal memory) and the response to antidepressant treatment during the 18 months follow-up
Measured: at 18 month
scores to Iowa Gambling Task
Studying the relation between scores to Iowa Gambling Task (assessment of decision making) and the response to antidepressant treatment during the 18 months follow-up
Measured: at 18 month
score to the brixton test
Studying the relation between score to the brixton test (assessment of mental flexibility) and the response to antidepressant treatment during the 18 months follow-up
Measured: at 18 month
verbal fluency
Studying the relation between score to verbal fluency and the response to antidepressant treatment during the 18 months follow-up
Measured: at 18 month
scores to Reversal Learning Task
Studying the relation between scores to Reversal learning task (assessment of decision making) and the response to antidepressant treatment during the 18 months follow-up
Measured: at 18 month
scores to the Attentional Stroop test
Studying the relation between scores to Attentional Stroop test and the response to antidepressant treatment during the 18 months follow-up
Measured: at 18 month
relation between inflammatory markers and the response to antidepressant treatment
Studying the relation between inflammatory markers at baseline and the response to antidepressant treatment during the 18 months follow-up
Measured: at 18 month
relation between thyroid function and the response to antidepressant treatment
Studying the relation between thyroid function at baseline and the response to antidepressant treatment during the 18 months follow-up
Measured: at 18 month
relation between lipid profile and the response to antidepressant treatment
Studying the relation between lipid profile at baseline and the response to antidepressant treatment during the 18 months follow-up
Measured: at 18 month
relation between pharmacological assays and the response to antidepressant treatment
Studying the relation between pharmacological assays at baseline and t the response to antidepressant treatment during the 18 months follow-up
Measured: at 18 month
lethality of past SB
Studying the relation between the lethality of past SB (assessed by the Columbia Suicide History Form) and the occurrence of new SB during the 18 months follow-up
Measured: at 18 month
Depression (Inventory of Depressive Symptomatology)
Studying the relation between score to the Inventory Of Depressive Symptomatology and the occurrence of new SB during the 18 months follow-up
Measured: at 18 month
Depression (Beck Depression Inventory)
Studying the relation between score to the Beck Depression Inventory and the occurrence of new SB during the 18 months follow-up
Measured: at 18 month
depression level (Beck depression Inventory)
Studying the relation between score to the Beck depression Inventory and the response to antidepressant treatment during the 18 months follow-up
Measured: at 18 month
depression level (Quick Inventory of Depressive Symptomatology)
Studying the relation between score to the Quick Inventory of Depressive Symptomatology and the response to antidepressant treatment during the 18 months follow-up
Measured: at 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJun 2012
- Primary completionDec 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Current Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 555 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847741
- Sponsor's protocol ID
- UF 8921
- Other IDs
- 2011-A01657-34
- Status last verified
- Jul 2016
- First submitted
- 15 Jul 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Nature of Total Cholesterol Threshold: Possible Link to Suicidal Behavior
- ClinicalTrials.gov ID
- NCT02847741
- Acronym / sponsor ID
- UF 8921
- Conditions
- Current Major Depressive Disorder
- Keywords
- Depression, Cholesterol, Suicidal behavior, Predictive factor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 555 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 28 Jul 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.
Suicidal behavior (SB) is a public health problem. The clinical model currently admitted to the understanding of SB is a stress vulnerability model, but so far, all scientific works has no clinical application. The management of psychiatric patients, including depressed subjects, faces the inability to detect those with a high risk of SB. Many studies have shown a link between low cholesterol and SB. A study has recently proposed a total cholesterol threshold below which the risk of suicide could be increased. However, a prospective study is needed to assess the predictive nature of such an indicator.
Detailed description
Investigators propose to assess, within a cohort of patients, the predictive value of a total cholesterol threshold in the occurrence of SB.
555 inpatients suffering from a current Major depressive disorder (MDD), hospitalized in the Department of Emergency Psychiatry and Post Acute Care will be recruited.
Each patient will attend a total of 5 visits during a follow-up period of 18 months (visits at 1, 3, 6, 12, and 18 months)
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Major depressive episode | Other | Other: patient's routine careDepressive patients will be assessed by interview (psychiatrists), questionnaires and blood sampling, as the inpatients's routine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Major
- Meet the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM) criteria for a major depressive episode
- Subject who signed the non-opposition form
- Able to understand the nature, purpose and methodology of the study
- Able to understand and perform the clinical and neuropsychological evaluations.
Key exclusion criteria (7 listed)
- Subject whose primary psychiatric diagnosis is not a major depressive episode according to DSM-IV criteria (the existence of psychiatric comorbidity is not a criterion for non-inclusion)
- Refusal of participation
- Subject Deprived of liberty (by judicial or administrative decision)
- Subject protected by law (guardianship)
- Subject exclusion period in relation to another protocol
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 |
|---|---|---|
| patient's routine careInterview by psychiatrists, questionnaires, blood analysis | Other | Major depressive episode |
Primary outcome
frequency of suicide attempts
Time frame: at 18 month
frequency of suicide attempts during the 18months follow-up, according to the total cholesterol threshold at baseline. The biological sampling is carried out after 12 hours of fasting.
40 secondary outcomes
number of past SB
Time frame: at 18 month
moral pain
Time frame: at 18 month
physical pain
Time frame: at 18 month
suicidal ideation
Time frame: at 18 month
depression (Quick Inventory of Depressive Symptomatology)
Time frame: at 18 month
history of childhood abuse
Time frame: at 18 month
National Adult Reading Test score
Time frame: at 18 month
scores to California Verbal Learning Test
Time frame: at 18 month
scores to Iowa Gambling Task Time frame: 18 months
Time frame: at 18 month
score to the brixton test
Time frame: at 18 month
scores to verbal fluency
Time frame: at 18 month
scores to Reversal Learning Task
Time frame: at 18 month
scores to the Attentional Stroop test
Time frame: at 18 month
relation between inflammatory markers and the occurrence of SB
Time frame: at 18 month
relation between thyroid function and the occurrence of SB
Time frame: at 18 month
relation between lipid profile and the occurrence of SB
Time frame: at 18 month
relation between pharmacological assays and the occurrence of SB
Time frame: at 18 month
relation between the characteristic of the mood depressive disorder (unipolar or bipolar depression) and the predictive or vulnerability factors of SB
Time frame: at 18 month
the characteristic of past SB
Time frame: at 18 month
moral pain
Time frame: at 18 month
physical pain
Time frame: at 18 month
suicidal ideation
Time frame: at 18 month
depression level (Inventory of Depressive Symptomatology)
Time frame: at 18 month
history of childhood abuse
Time frame: at 18 month
National Adult Reading Test score ( NART)
Time frame: at 18 month
scores to California Verbal Learning Test
Time frame: at 18 month
scores to Iowa Gambling Task
Time frame: at 18 month
score to the brixton test
Time frame: at 18 month
verbal fluency
Time frame: at 18 month
scores to Reversal Learning Task
Time frame: at 18 month
scores to the Attentional Stroop test
Time frame: at 18 month
relation between inflammatory markers and the response to antidepressant treatment
Time frame: at 18 month
relation between thyroid function and the response to antidepressant treatment
Time frame: at 18 month
relation between lipid profile and the response to antidepressant treatment
Time frame: at 18 month
relation between pharmacological assays and the response to antidepressant treatment
Time frame: at 18 month
lethality of past SB
Time frame: at 18 month
Depression (Inventory of Depressive Symptomatology)
Time frame: at 18 month
Depression (Beck Depression Inventory)
Time frame: at 18 month
depression level (Beck depression Inventory)
Time frame: at 18 month
depression level (Quick Inventory of Depressive Symptomatology)
Time frame: at 18 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient's routine care in people with Current Major Depressive Disorder, run by University Hospital, Montpellier 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Jul 2016. 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?
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?
frequency of suicide attempts (time frame: at 18 month). 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 28 Jul 2016.