This trial has been completed.

Condition mental disorders
Sponsor Norwegian University of Science and Technology
Collaborator University of Bergen
Start date September 2011
End date March 2012
Trial size 384 participants
Trial identifier NCT01415323, Acute agitation


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

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.

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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.

Additional Information

Official title Agitation in the Acute Psychiatric Department
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Norwegian University of Science and Technology.