Agitation in the Acute Psychiatric Department

Mental Disorders Clinical Trial

Official title:

Agitation in the Acute Psychiatric Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415323
• Other study ID #: Acute agitation
• Status: Completed
• Start date: September 2011
• Est. completion date: March 2012

Study information

• Verified date: January 2022
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychomotor Agitation

Locations

Country	Name	City	State
Norway	St Olavs University Hospital, Department of Acute Psychiatry Østmarka	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Deakin University, University of Bergen, University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Nakken EI, Grinde F, Vaaler A, Drange OK, Brodtkorb E, Sæther 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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