Mental DisordersNCT01415323
Agitation in the Acute Psychiatric Department
An observational study of Mental Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mental Disorders
- How many people
- 384 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2011to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All acutely admitted psychiatric in-patients from a defined catchment area.
Who may be able to join
- All consecutive acutely admitted in-patients are asked for participation.
Who cannot join
- Patients not willing to sign informed consent form.
- Patients not speaking English or Norwegian.
Trial locations and contacts
1 site in 1 country.
Norway1 site
St Olavs University Hospital, Department of Acute Psychiatry Østmarka
Trondheim, 7441
About this study
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.
Read the 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.
- Conditions
- Mental Disorders
- Keywords
- Emergency services, psychiatric, Psychomotor agitation, Suicide, Violence
- Medical subject headings
- Mental Disorders, Psychomotor Agitation, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acutely admitted psychiatric in-patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 years.
Secondary outcomes (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.
Measured: Up 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, University of Oslo, Deakin University
- Responsible party
- Sponsor
- Investigators
- Arne E Vaaler, PhD, MD, Study chair, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415323
- Sponsor's protocol ID
- Acute agitation
- Status last verified
- Nov 2024
- First submitted
- 6 Jul 2011
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. doi: 10.1186/s12888-016-1124-y.
PubMed 27855664Nakken EI, Grinde F, Vaaler A, Drange OK, Brodtkorb E, Saether 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.
PubMed 34911471Krane-Gartiser K, Vaaler AE, Fasmer OB, Sorensen K, Morken G, Scott J. Variability of activity patterns across mood disorders and time of day. BMC Psychiatry. 2017 Dec 19;17(1):404. doi: 10.1186/s12888-017-1574-x.
PubMed 29258468
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agitation in the Acute Psychiatric Department
- ClinicalTrials.gov ID
- NCT01415323
- Acronym / sponsor ID
- Acute agitation
- Conditions
- Mental Disorders
- Keywords
- Emergency services, psychiatric, Psychomotor agitation, Suicide, Violence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University of Bergen, University of Oslo, Deakin University
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acutely admitted psychiatric in-patients | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All acutely admitted psychiatric in-patients from a defined catchment area.
Key inclusion criteria (1 listed)
- All consecutive acutely admitted in-patients are asked for participation.
Key exclusion criteria (2 listed)
- Patients not willing to sign informed consent form.
- Patients not speaking English or Norwegian.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Results publication: PubMed 27855664Sallaup 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. doi: 10.1186/s12888-016-1124-y.
- Results publication: PubMed 34911471Nakken EI, Grinde F, Vaaler A, Drange OK, Brodtkorb E, Saether 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.
- Derived from this study: PubMed 29258468Krane-Gartiser K, Vaaler AE, Fasmer OB, Sorensen K, Morken G, Scott J. Variability of activity patterns across mood disorders and time of day. BMC Psychiatry. 2017 Dec 19;17(1):404. doi: 10.1186/s12888-017-1574-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne E Vaaler, PhD, MD study chair
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01415323, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.