Agitation in the Acute Psychiatric Department

January 15, 2022 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Completed

Conditions

Detailed Description

The patients are assessed with three rating scales (Components of agitation, The PANSS-EC, The Brøset Violence Checklist) measuring agitation at admittance and day three thus providing a measurement of the differences during three days of in-patient stay. Therapeutic measures and interventions taken are assessed daily with a 18-item checklist. Threatening and violent incidents are recorded with The SOAS-R.

Blood samples for immunological parameters are taken at admittance and discharge giving opportunity to assess changes through the acute psychiatric condition. Urine and blood samples are taken at admittance to assess substance use and medications.

The patients are assess with two self-rating VAS-scales at discharge assessing the suicidal intentions they have had during the stay, aspects of clinical history and assessment for personality disorders.

Study Type

Observational

Enrollment (Actual)

384

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7441
        • St Olavs University Hospital, Department of Acute Psychiatry Østmarka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Acutely admitted psychiatric in-patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Up to 4 years.
Up to 4 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Up 4 years
Up 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

University of Oslo
University of Bergen
Deakin University

Investigators

  • Study Chair: Arne E Vaaler, PhD, MD, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

July 6, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (Estimate)

August 11, 2011

Study Record Updates

Last Update Posted (Actual)

January 31, 2022

Last Update Submitted That Met QC Criteria

January 15, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Acute agitation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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