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CompletedNCT02721316SIPRéSUpdated Jun 3, 2026

Outpatient Nurse Monitoring Under the Prevention of Recurrent Suicidal

An interventional study of Supported with intensive nursing follow post hospitalization in Mood Disorder and Reactive Depression, sponsored by University Hospital, Montpellier. Completed. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
380
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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 (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.

02

Conditions studied

  • Mood Disorder
  • Reactive Depression
03

In context

Mood Disorders

561 studies on the registry are indexed under Mood Disorders; 105 are open to participants now.

This study's enrollment of 380 is above the median of 80 across 419 interventional studies indexed under Mood Disorders.

Browse Mood Disorders studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
380 participants (actual)

Study arms

  • Experimental
    Supported with intensive nursing follow

    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.

    Other: Supported with intensive nursing follow post hospitalization

  • No intervention
    usual care

    For control patients, monitoring will be identical to their usual care as part of their pathology.

Interventions

  • OtherSupported with intensive nursing follow post hospitalization

    Intensive nursing follow post - hospitalization

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months from EPAC (Emergency Psychiatry and Acute Care) discharge

Secondary outcomes

  1. Suicide attempt recurrence

    Occurrence of at least one suicide attempt, defined as medically documented or self-reported attempt or death by suicide

    Time frame: 12 months from EPAC discharge

  2. 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

    Time frame: 12 months from EPAC discharge

  3. Worsening of suicidal ideations

    Increase ≥2 points on the C-SSRS severity score compared with EPAC discharge

    Time frame: 3 months, 6 months and 12 months after EPAC discharge

  4. Frequency of suicidal ideation

    Frequency of suicidal ideation measured with the C-SSRS (Columbia-Suicide Severity Rating Scale).

    Time frame: At inclusion, at EPAC discharge, and at 3 months, 6 months and12 months after EPAC discharge

  5. Intensity of suicidal ideation

    Intensity of suicidal ideation measured with the C-SSRS (Columbia-Suicide Severity Rating Scale).

    Time frame: At inclusion, at EPAC discharge, and at 3 months, 6 months and 12 months after EPAC discharge

  6. Psychological pain

    Psychological pain measured with Visual Analog Scale (VAS)

    Time frame: At inclusion, at EPAC discharge, and at 3 months, 6 months and 12 months after EPAC discharge

  7. Number of unscheduled healthcare visits for suicidal ideation

    Time frame: At 3 months, 6 months and12 months after EPAC discharge

  8. All-cause mortality and mortality by suicide

    Time frame: At 3 months, 6 months and12 months after EPAC discharge

  9. Total duration of psychiatric hospitalization during the year following the suicide attempt

    Time frame: At 3 months, 6 months and12 months after EPAC discharge

  10. Number of participants lost to follow-up at the end of the study

    Time frame: At 12 months after EPAC discharge

  11. Patient quality of life

    Time frame: At inclusion, at 3 months, 6 months and12 months after EPAC discharge

  12. Adherence to the therapeutic program proposed and/or prescribed in the service.

    Time frame: 12 months after EPAC discharge

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2016 to primary completion in May 2017, 12 months.

Of 151 non-industry interventional studies with no phase under Mood Disorders, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 12 months is below that.

Counting every sponsor, half of 162 studies reached it within 21 months; a quarter within 11 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 8, 2016
First posted
Mar 29, 2016
StartActual
May 2016
Primary completionActual
May 2017
CompletionActual
Oct 2021
Last update
Jun 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02721316
Responsible party
Sponsor
First posted
Mar 29, 2016
Start date
May 2016
Primary completion
May 2017
Completion
Oct 2021
Last update
Jun 3, 2026

Study contacts

Grégory Mykolow
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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