Mood DisorderSIPRéSNCT02721316
Outpatient Nurse Monitoring Under the Prevention of Recurrent Suicidal
A study testing Supported with intensive nursing follow post hospitalization in people with Mood Disorder and Reactive Depression, run by University Hospital, Montpellier.
Trial summary
To evaluate the impact of a specific nursing management (personalized and close, through consultation at the hospital, at home or by phone) monitoring in post-hospitalization, the suicide attempt of recurrence and suicidal crisis, in the year following a suicide attempt in patients suffering from a mood disorder… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mood Disorder, Reactive Depression
- What is being tested?
- Supported with intensive nursing follow post hospitalization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Oct 2021
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient suffering from a mood disorder (unipolar or bipolar) or reactive depression whose reason for hospitalization in the Psychiatric Emergency Unit Post has attempted suicide
Who cannot join
- Patients with bipolar disorder, current episode manic in
- Patient Hospitalized full-time (for high suicide risk incompatible with an output of emergencies or clinical transfer) within 3-5 days of the TS
- Patient suffering from a somatic pathology associated with the prognosis is committed in the short term.
- Patients suffering from a neurodegenerative pathology of dementia or pre-dementia types.
- Homeless Patient
About this study
Official title: Randomized Study of Ambulatory Monitoring Nurse Under the Prevention of Recurrent Suicidal
To evaluate the impact of a specific nursing management (personalized and close, through consultation at the hospital, at home or by phone) monitoring in post-hospitalization, the suicide attempt of recurrence and suicidal crisis, in the year following a suicide attempt in patients suffering from a mood disorder (unipolar or bipolar) or reactive depression.
Read the detailed description
Main objective: To evaluate the impact of a specific nursing management (personalized and close, through consultation at the hospital, at home or by phone) monitoring in post-hospitalization, the suicide attempt of recurrence and suicidal crisis, in the year following a suicide attempt in patients suffering from a mood disorder (unipolar or bipolar) or reactive depression.
Secondary objectives:
Studying during the year following the suicide attempt index, the impact of this device on:
- The frequency and intensity of suicidal ideation
- the spontaneous use of emergency care
- the death rate from suicide and other causes
- the cumulative duration of hospitalization for suicidal behavior
- The patient's quality of life
- the number of patients lost to at the end of search
Studying patient compliance with intensive nursing monitoring program.
To study the role of the nurse to determine the factors that promote the construction of a therapeutic alliance.
Establish a mapping of needs and resources suicidal patient for nursing care in post-emergency.
- Conditions
- Mood Disorder, Reactive Depression
- Being tested
- Supported with intensive nursing follow post hospitalization
- Medical subject headings
- Mood Disorders, Adjustment Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supported with intensive nursing follow post hospitalizationOther
Intensive nursing follow post - hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Supported with intensive nursing follow | Experimental | Supported with intensive nursing follow post hospitalization the team of hospital output of the unit to 12 weeks after discharge. These interviews will be conducted at the hospital, at home or by phone and their pace will be adjusted according to the patient's condition. The expected duration of close outpatient follow-up is of maximum 3 months. Receives: Other: Supported with intensive nursing follow post hospitalization |
| usual care | No intervention | For control patients, monitoring will be identical to their usual care as part of their pathology. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite suicidal outcome including suicidal attempt recurrence or hospitalization for suicidal crisis or worsening of suicidal ideation
Composite endpoint including any of the following events:
- Suicide attempt recurrence,
- Emergency hospitalization for suicidal crisis without suicide attempt
- Worsening of suicidal ideations defined as an increase ≥2 points on the C-SSRS severity subscale compared with EPAC discharge
Measured: 12 months from EPAC (Emergency Psychiatry and Acute Care) discharge
Secondary outcomes (12)
Suicide attempt recurrence
Occurrence of at least one suicide attempt, defined as medically documented or self-reported attempt or death by suicide
Measured: 12 months from EPAC discharge
Emergency hospitalization for suicidal crisis without attempt
Occurrence of at least one emergency hospitalization for suicidal crisis, defined as persistent and high-intensity suicidal ideations
Measured: 12 months from EPAC discharge
Worsening of suicidal ideations
Increase ≥2 points on the C-SSRS severity score compared with EPAC discharge
Measured: 3 months, 6 months and 12 months after EPAC discharge
Frequency of suicidal ideation
Frequency of suicidal ideation measured with the C-SSRS (Columbia-Suicide Severity Rating Scale).
Measured: At inclusion, at EPAC discharge, and at 3 months, 6 months and12 months after EPAC discharge
Intensity of suicidal ideation
Intensity of suicidal ideation measured with the C-SSRS (Columbia-Suicide Severity Rating Scale).
Measured: At inclusion, at EPAC discharge, and at 3 months, 6 months and 12 months after EPAC discharge
Psychological pain
Psychological pain measured with Visual Analog Scale (VAS)
Measured: At inclusion, at EPAC discharge, and at 3 months, 6 months and 12 months after EPAC discharge
Number of unscheduled healthcare visits for suicidal ideation
Measured: At 3 months, 6 months and12 months after EPAC discharge
All-cause mortality and mortality by suicide
Measured: At 3 months, 6 months and12 months after EPAC discharge
Total duration of psychiatric hospitalization during the year following the suicide attempt
Measured: At 3 months, 6 months and12 months after EPAC discharge
Number of participants lost to follow-up at the end of the study
Measured: At 12 months after EPAC discharge
Patient quality of life
Measured: At inclusion, at 3 months, 6 months and12 months after EPAC discharge
Adherence to the therapeutic program proposed and/or prescribed in the service.
Measured: 12 months after EPAC discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017
- Study completionOct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grégory Mykolow, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721316
- Sponsor's protocol ID
- UF9533
- Acronym
- SIPRéS
- Status last verified
- Feb 2022
- First submitted
- 8 Mar 2016
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Ambulatory Monitoring Nurse Under the Prevention of Recurrent Suicidal
- ClinicalTrials.gov ID
- NCT02721316
- Acronym / sponsor ID
- SIPRéS / UF9533
- Conditions
- Mood Disorder, Reactive Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Oct 2021 (actual)
- First posted
- 29 Mar 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.
To evaluate the impact of a specific nursing management (personalized and close, through consultation at the hospital, at home or by phone) monitoring in post-hospitalization, the suicide attempt of recurrence and suicidal crisis, in the year following a suicide attempt in patients suffering from a mood disorder (unipolar or bipolar) or reactive depression.
Detailed description
Main objective: To evaluate the impact of a specific nursing management (personalized and close, through consultation at the hospital, at home or by phone) monitoring in post-hospitalization, the suicide attempt of recurrence and suicidal crisis, in the year following a suicide attempt in patients suffering from a mood disorder (unipolar or bipolar) or reactive depression.
Secondary objectives:
Studying during the year following the suicide attempt index, the impact of this device on:
- The frequency and intensity of suicidal ideation
- the spontaneous use of emergency care
- the death rate from suicide and other causes
- the cumulative duration of hospitalization for suicidal behavior
- The patient's quality of life
- the number of patients lost to at the end of search
Studying patient compliance with intensive nursing monitoring program.
To study the role of the nurse to determine the factors that promote the construction of a therapeutic alliance.
Establish a mapping of needs and resources suicidal patient for nursing care in post-emergency.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supported with intensive nursing follow | Experimental | Other: Supported with intensive nursing follow post hospitalizationSupported with intensive nursing follow post hospitalization the team of hospital output of the unit to 12 weeks after discharge. These interviews will be conducted at the hospital, at home or by phone and their pace will be adjusted according to the patient's condition. The expected duration of close outpatient follow-up is of maximum 3 months. |
| usual care | No intervention | –For control patients, monitoring will be identical to their usual care as part of their pathology. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient suffering from a mood disorder (unipolar or bipolar) or reactive depression whose reason for hospitalization in the Psychiatric Emergency Unit Post has attempted suicide
Key exclusion criteria (5 listed)
- Patients with bipolar disorder, current episode manic in
- Patient Hospitalized full-time (for high suicide risk incompatible with an output of emergencies or clinical transfer) within 3-5 days of the TS
- Patient suffering from a somatic pathology associated with the prognosis is committed in the short term.
- Patients suffering from a neurodegenerative pathology of dementia or pre-dementia types.
- Homeless Patient
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 |
|---|---|---|
| Supported with intensive nursing follow post hospitalizationIntensive nursing follow post - hospitalization | Other | Supported with intensive nursing follow |
Primary outcome
Composite suicidal outcome including suicidal attempt recurrence or hospitalization for suicidal crisis or worsening of suicidal ideation
Time frame: 12 months from EPAC (Emergency Psychiatry and Acute Care) discharge
Composite endpoint including any of the following events: * Suicide attempt recurrence, * Emergency hospitalization for suicidal crisis without suicide attempt * Worsening of suicidal ideations defined as an increase ≥2 points on the C-SSRS severity subscale compared with EPAC discharge
12 secondary outcomes
Suicide attempt recurrence
Time frame: 12 months from EPAC discharge
Emergency hospitalization for suicidal crisis without attempt
Time frame: 12 months from EPAC discharge
Worsening of suicidal ideations
Time frame: 3 months, 6 months and 12 months after EPAC discharge
Frequency of suicidal ideation
Time frame: At inclusion, at EPAC discharge, and at 3 months, 6 months and12 months after EPAC discharge
Intensity of suicidal ideation
Time frame: At inclusion, at EPAC discharge, and at 3 months, 6 months and 12 months after EPAC discharge
Psychological pain
Time frame: At inclusion, at EPAC discharge, and at 3 months, 6 months and 12 months after EPAC discharge
Number of unscheduled healthcare visits for suicidal ideation
Time frame: At 3 months, 6 months and12 months after EPAC discharge
All-cause mortality and mortality by suicide
Time frame: At 3 months, 6 months and12 months after EPAC discharge
Total duration of psychiatric hospitalization during the year following the suicide attempt
Time frame: At 3 months, 6 months and12 months after EPAC discharge
Number of participants lost to follow-up at the end of the study
Time frame: At 12 months after EPAC discharge
Patient quality of life
Time frame: At inclusion, at 3 months, 6 months and12 months after EPAC discharge
Adherence to the therapeutic program proposed and/or prescribed in the service.
Time frame: 12 months after EPAC discharge
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 3 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Grégory Mykolow principal investigator
University Hospital, Montpellier
Questions about this trial
What is this clinical trial studying?
A study testing Supported with intensive nursing follow post hospitalization in people with Mood Disorder and Reactive Depression, run by University Hospital, Montpellier.
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 1 inclusion and 5 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 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Composite suicidal outcome including suicidal attempt recurrence or hospitalization for suicidal crisis or worsening of suicidal ideation (time frame: 12 months from EPAC (Emergency Psychiatry and Acute Care) discharge). 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 3 Jun 2026.