NCT01415323

Brief Summary

Agitation is associated with a number of acute psychiatric conditions, and frequent in acute psychiatric admissions. It is associated with violence towards others, and strongly associated with in-patient suicides. The main aims of the study are to assess different clinical presentations of agitation at admittance, and to assess the consequences of these different clinical presentations during the first three days of the stay.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
384

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
21 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

July 6, 2011

Last Update Submit

November 18, 2024

Conditions

Keywords

Emergency services, psychiatricPsychomotor agitationSuicideViolence

Outcome Measures

Primary Outcomes (1)

  • the number of violent or threatening incidents the first three days of inpatient stay measured with The Staff Observation Aggression Scale - Revised (SOAS-R) with positive scorings of incidents with a severity score >8.

    Up to 4 years.

Secondary Outcomes (1)

  • the degree of suicidal intention the first three days of inpatient stay measured with the 10 item self-rating VAS-scale administered at discharge from the acute department.

    Up 4 years

Study Arms (1)

Acutely admitted psychiatric in-patients

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All acutely admitted psychiatric in-patients from a defined catchment area.

You may qualify if:

  • All consecutive acutely admitted in-patients are asked for participation.

You may not qualify if:

  • Patients not willing to sign informed consent form.
  • Patients not speaking English or Norwegian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs University Hospital, Department of Acute Psychiatry Østmarka

Trondheim, 7441, Norway

Location

Related Publications (3)

  • Sallaup TV, Vaaler AE, Iversen VC, Guzey IC. Challenges in detecting and diagnosing substance use in women in the acute psychiatric department: a naturalistic cohort study. BMC Psychiatry. 2016 Nov 17;16(1):406. doi: 10.1186/s12888-016-1124-y.

  • Nakken EI, Grinde F, Vaaler A, Drange OK, Brodtkorb E, Saether SG. Epilepsy and other seizure disorders in acute psychiatric inpatients. BMC Psychiatry. 2021 Dec 15;21(1):626. doi: 10.1186/s12888-021-03619-y.

  • Krane-Gartiser K, Vaaler AE, Fasmer OB, Sorensen K, Morken G, Scott J. Variability of activity patterns across mood disorders and time of day. BMC Psychiatry. 2017 Dec 19;17(1):404. doi: 10.1186/s12888-017-1574-x.

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples are collected for storage and analyses both at admittance and discharge from the psychiatric acute department.

MeSH Terms

Conditions

Mental DisordersPsychomotor AgitationSuicide

Condition Hierarchy (Ancestors)

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

Study Officials

  • Arne E Vaaler, PhD, MD

    Norwegian University of Science and Technology

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

July 6, 2011

First Posted

August 11, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

November 19, 2024

Record last verified: 2024-11

Locations