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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
Sponsor:
Collaborators:
University of Bergen
University of Oslo
Deakin University
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date July 6, 2011
First Posted Date August 11, 2011
Last Update Posted Date November 22, 2016
Study Start Date September 2011
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 10, 2011)
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. ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 10, 2011)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Agitation in the Acute Psychiatric Department
Official Title Agitation in the Acute Psychiatric Department
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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples are collected for storage and analyses both at admittance and discharge from the psychiatric acute department.
Sampling Method Probability Sample
Study Population All acutely admitted psychiatric in-patients from a defined catchment area.
Condition Mental Disorders
Intervention Not Provided
Study Groups/Cohorts Acutely admitted psychiatric in-patients
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 21, 2016)
384
Original Estimated Enrollment
 (submitted: August 10, 2011)
400
Actual Study Completion Date March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT01415323
Other Study ID Numbers Acute agitation
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor Norwegian University of Science and Technology
Collaborators
  • University of Bergen
  • University of Oslo
  • Deakin University
Investigators
Study Chair: Arne E Vaaler, PhD, MD Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date November 2016