Agitation in the Acute Psychiatric Department

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Bergen
University of Oslo
Deakin University
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01415323
First received: July 6, 2011
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

Agitation is frequent in acute psychiatric admissions. Agitation is associated to a number of acute psychiatric conditions. Agitation is associated to violence towards others. It is strongly associated to 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.


Condition
Acutely Admitted Psychiatric Patients

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Agitation in the Acute Psychiatric Department

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 400
Study Start Date: September 2011
Estimated Study Completion Date: April 2020
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acutely admitted psychiatric in-patients

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415323

Locations
Norway
St Olavs University Hospital, Department of Acute Psychiatry Østmarka
Trondheim, Norway, 7441
Sponsors and Collaborators
Norwegian University of Science and Technology
University of Bergen
University of Oslo
Deakin University
Investigators
Study Chair: Arne E Vaaler, PhD, MD Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01415323     History of Changes
Other Study ID Numbers: Acute agitation
Study First Received: July 6, 2011
Last Updated: July 25, 2014
Health Authority: Norway: Ethics Committee

Keywords provided by Norwegian University of Science and Technology:
Psychiatry
emergency
acute
agitation
suicide
violence

ClinicalTrials.gov processed this record on October 19, 2014