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Agitation in the Acute Psychiatric Department

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ClinicalTrials.gov Identifier: NCT01415323
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : November 22, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Mental Disorders

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 Design

Study Type : Observational
Actual Enrollment : 384 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Agitation in the Acute Psychiatric Department
Study Start Date : September 2011
Primary Completion Date : March 2012
Study Completion Date : March 2012
Groups and Cohorts

Acutely admitted psychiatric in-patients

Outcome Measures

Primary Outcome Measures :
  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. [ Time Frame: Up to 4 years. ]

Secondary Outcome Measures :
  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. [ Time Frame: Up 4 years ]

Biospecimen Retention:   Samples With DNA
Blood samples are collected for storage and analyses both at admittance and discharge from the psychiatric acute department.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All acutely admitted psychiatric in-patients from a defined catchment area.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415323

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

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01415323     History of Changes
Other Study ID Numbers: Acute agitation
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016

Keywords provided by Norwegian University of Science and Technology:
Emergency services, psychiatric
Psychomotor agitation

Additional relevant MeSH terms:
Psychomotor Agitation
Mental Disorders
Psychotic Disorders
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders