NCT02625818

Brief Summary

A major proportion of patients admitted to psychiatric acute and emergency departments have symptoms, behaviors or function influenced by implicit or explicit suicidal intention (tendency towards self-harm, or suicide attempt). There is an increased risk of suicide in the acute phase during in-patient stay and after discharge. At present there is no satisfactory tool to predict post-discharge suicide risk. Multidimensional rating is expected to have better predictive properties than one-dimensional rating for suicidal behavior during in -patient stay and two years after discharge. Multidimensional rating assesses anxiety, panic, agitation, suicidal thoughts and ideations, as well as therapist's reactions during interviews. In the present study the predictive properties of two rating scales for suicidal behavior during in-patient stay and two years after will be compared. One of these is a multidimensional scale: "Multidimensional Assessment of Suicide Risk" (MARIS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

4 years

First QC Date

December 4, 2015

Last Update Submit

November 18, 2024

Conditions

Keywords

Emergency Services, PsychiatricPrognosisBiological markersAnxietyPanicPsychomotor AgitationSelf-injurious Behavior

Outcome Measures

Primary Outcomes (1)

  • self-inflicted, potentially injurious behavior with intention to die defined as acts needing attendance by physician

    during in-patient stay

    2 weeks

Secondary Outcomes (1)

  • suicide

    2 years after discharge

Study Arms (1)

acute psychiatric condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the psychiatric acute department for central Norway, St Olavs University Hospital, Trondheim. The department has a catchment area of approximately 240000 inhabitants ≥ 18 years. The hospital has close to 2000 admittances each year

You may qualify if:

  • acute agitated condition
  • informed consent

You may not qualify if:

  • Drug abuse
  • in-patient stay for a fixed time at regular intervals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital, Østmarka psychiatric department

Trondheim, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples (plasma and serum)

MeSH Terms

Conditions

Mental DisordersAnxiety DisordersPsychomotor AgitationSelf-Injurious Behavior

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Study Officials

  • Randolf Terje Vågen

    St Olavs Hospital, Division of Mental Health Care

    STUDY DIRECTOR
  • Nanna Sønnichsen Kayed

    Department of Mental Health, Faculty of Medicine and Health, NTNU

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2015

First Posted

December 9, 2015

Study Start

January 1, 2016

Primary Completion

January 1, 2020

Study Completion

January 1, 2021

Last Updated

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations