DepressionNCT05046587
Characterization of Suicidal Depression
An observational study of Depression, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Antidepressants are widely used to prevent suicidal risk. However, even though the use of antidepressants has been associated with a 40-60% decrease in suicidal risk, they do not seem to be sufficient and appropriate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- How many people
- 898 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2021to 30 Sep 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Depressed patients with and without suicidal ideation, admitted to the Department of Emergency Psychiatry and Acute Care (Montpellier University Hospital) and enrolled in one of the department's clinical studies.
Who may be able to join
- Over 18 years old
- Hospitalization in the Department of Emergency Psychiatry and Acute Care (Montpellier University Hospital) between 2012 and 2019
- Having being enrolled in one the department's clinical studies between 2012 and 2019
- Moderate to severe characterized depressive episode according to DSM-5 diagnostic criteria (severity assessed with BDI, IDSC-30 and QIDS)
Who cannot join
- Protection by law (guardianship or curatorship)
- Deprivation of liberty (by judicial or administrative decision)
- Bipolar disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Suicidal Depression Within a Large Cohort of Inpatients: a One-year Prospective Study.
Antidepressants are widely used to prevent suicidal risk. However, even though the use of antidepressants has been associated with a 40-60% decrease in suicidal risk, they do not seem to be sufficient and appropriate. Indeed recent studies have shown that patients with a history of suicide attempt and/or with current suicidal ideation (SI) respond less well to antidepressant treatments. This suggests that patients with depression with SI may be different from those with depression without SI, thus requiring specific treatments for both SI reduction and depressive remission. In other words, suicidal depression may be a specific subtype of depression.
The study aims to characterize the clinical phenotype of patients with suicidal depression vs. those without suicidal depression, and to assess the occurrence of suicidal events at one year in patients with suicidal depression vs. without suicidal depression.
All data having already been collected during the particpation of patients in various clinical research studies of the department
- Conditions
- Depression
- Keywords
- Suicide, Suicidal Ideation, Suicidal Depression
- Medical subject headings
- Depression, Suicide, Suicidal Ideation
What is being measured
The primary outcome is the main question the study is designed to answer.
characterization of the patient clinical phenotype
characterization of the patient clinical phenotype
Measured: day 1
Secondary outcomes (3)
Suicidal events at one year
Occurrence of suicidal events (actual, interrupted and aborted or self-aborted suicide attempts) assessed with C-SSRS suicidal behaviour subscale (4 yes/no questions)
Measured: 1 year
Hospitalization for suicidal ideation
Occurrence of hospitalization for suicidal ideation, based on the patient medical record
Measured: 1 year
Suicidal events at one year
Occurrence of suicidal events (actual, interrupted and aborted or self-aborted suicide attempts) based on the patient medical records
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Jun 2021
- Primary completion1 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 898 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bénédicte NOBILE, PharmD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046587
- Sponsor's protocol ID
- RECHMPL21_0395
- Status last verified
- Nov 2021
- First submitted
- 5 Jul 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Suicidal Depression Within a Large Cohort of Inpatients: a One-year Prospective Study.
- ClinicalTrials.gov ID
- NCT05046587
- Acronym / sponsor ID
- RECHMPL21_0395
- Conditions
- Depression
- Keywords
- Suicide, Suicidal Ideation, Suicidal Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 898 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 16 Sep 2021 (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.
Antidepressants are widely used to prevent suicidal risk. However, even though the use of antidepressants has been associated with a 40-60% decrease in suicidal risk, they do not seem to be sufficient and appropriate. Indeed recent studies have shown that patients with a history of suicide attempt and/or with current suicidal ideation (SI) respond less well to antidepressant treatments. This suggests that patients with depression with SI may be different from those with depression without SI, thus requiring specific treatments for both SI reduction and depressive remission. In other words, suicidal depression may be a specific subtype of depression.
The study aims to characterize the clinical phenotype of patients with suicidal depression vs. those without suicidal depression, and to assess the occurrence of suicidal events at one year in patients with suicidal depression vs. without suicidal depression.
All data having already been collected during the particpation of patients in various clinical research studies of the department
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Depressed patients with and without suicidal ideation, admitted to the Department of Emergency Psychiatry and Acute Care (Montpellier University Hospital) and enrolled in one of the department's clinical studies.
Key inclusion criteria (4 listed)
- Over 18 years old
- Hospitalization in the Department of Emergency Psychiatry and Acute Care (Montpellier University Hospital) between 2012 and 2019
- Having being enrolled in one the department's clinical studies between 2012 and 2019
- Moderate to severe characterized depressive episode according to DSM-5 diagnostic criteria (severity assessed with BDI, IDSC-30 and QIDS)
Key exclusion criteria (3 listed)
- Protection by law (guardianship or curatorship)
- Deprivation of liberty (by judicial or administrative decision)
- Bipolar disorder
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
characterization of the patient clinical phenotype
Time frame: day 1
characterization of the patient clinical phenotype
3 secondary outcomes
Suicidal events at one year
Time frame: 1 year
Hospitalization for suicidal ideation
Time frame: 1 year
Suicidal events at one year
Time frame: 1 year
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 15 Nov 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Bénédicte NOBILE, PharmD, PhD principal investigator
University Hospital, Montpellier
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 Depression, 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 4 inclusion and 3 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 15 Nov 2021. 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?
characterization of the patient clinical phenotype (time frame: day 1). 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 15 Nov 2021.