Mental DisordersGAPNCT02625818
The Genetic and Affective Prediction Study
An observational study of Mental Disorders, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
A major proportion of patients admitted to psychiatric acute and emergency departments have symptoms, behaviors or function influenced by implicit or explicit suicidal intention (tendency towards self-harm, or suicide attempt). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders
- How many people
- 400 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2016to Jan 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the psychiatric acute department for central Norway, St Olavs University Hospital, Trondheim. The department has a catchment area of approximately 240000 inhabitants ≥ 18 years. The hospital has close to 2000 admittances each year
Who may be able to join
- acute agitated condition
- informed consent
Who cannot join
- Drug abuse
- in-patient stay for a fixed time at regular intervals
Trial locations and contacts
1 site in 1 country.
About this study
A major proportion of patients admitted to psychiatric acute and emergency departments have symptoms, behaviors or function influenced by implicit or explicit suicidal intention (tendency towards self-harm, or suicide attempt). There is an increased risk of suicide in the acute phase during in-patient stay and after discharge. At present there is no satisfactory tool to predict post-discharge suicide risk.
Multidimensional rating is expected to have better predictive properties than one-dimensional rating for suicidal behavior during in -patient stay and two years after discharge. Multidimensional rating assesses anxiety, panic, agitation, suicidal thoughts and ideations, as well as therapist's reactions during interviews. In the present study the predictive properties of two rating scales for suicidal behavior during in-patient stay and two years after will be compared. One of these is a multidimensional scale: "Multidimensional Assessment of Suicide Risk" (MARIS).
- Conditions
- Mental Disorders
- Keywords
- Emergency Services, Psychiatric, Prognosis, Biological markers, Anxiety, Panic, Psychomotor Agitation, Self-injurious Behavior
- Medical subject headings
- Mental Disorders, Anxiety Disorders, Psychomotor Agitation, Self-Injurious Behavior
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 |
|---|---|---|
| acute psychiatric condition | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-inflicted, potentially injurious behavior with intention to die defined as acts needing attendance by physician
during in-patient stay
Measured: 2 weeks
Secondary outcomes (1)
suicide
Measured: 2 years after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2020
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Randolf Terje Vågen, Study director, St Olavs Hospital, Division of Mental Health CareNanna Sønnichsen Kayed, Study director, Department of Mental Health, Faculty of Medicine and Health, NTNU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625818
- Sponsor's protocol ID
- 2014/1751
- Acronym
- GAP
- Status last verified
- Nov 2024
- First submitted
- 4 Dec 2015
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Genetic and Affective Prediction Study
- ClinicalTrials.gov ID
- NCT02625818
- Acronym / sponsor ID
- GAP / 2014/1751
- Conditions
- Mental Disorders
- Keywords
- Emergency Services, Psychiatric, Prognosis, Biological markers, Anxiety, Panic, Psychomotor Agitation, Self-injurious Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 9 Dec 2015 (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.
A major proportion of patients admitted to psychiatric acute and emergency departments have symptoms, behaviors or function influenced by implicit or explicit suicidal intention (tendency towards self-harm, or suicide attempt). There is an increased risk of suicide in the acute phase during in-patient stay and after discharge. At present there is no satisfactory tool to predict post-discharge suicide risk.
Multidimensional rating is expected to have better predictive properties than one-dimensional rating for suicidal behavior during in -patient stay and two years after discharge. Multidimensional rating assesses anxiety, panic, agitation, suicidal thoughts and ideations, as well as therapist's reactions during interviews. In the present study the predictive properties of two rating scales for suicidal behavior during in-patient stay and two years after will be compared. One of these is a multidimensional scale: "Multidimensional Assessment of Suicide Risk" (MARIS).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute psychiatric condition | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the psychiatric acute department for central Norway, St Olavs University Hospital, Trondheim. The department has a catchment area of approximately 240000 inhabitants ≥ 18 years. The hospital has close to 2000 admittances each year
Key inclusion criteria (2 listed)
- acute agitated condition
- informed consent
Key exclusion criteria (2 listed)
- Drug abuse
- in-patient stay for a fixed time at regular intervals
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
self-inflicted, potentially injurious behavior with intention to die defined as acts needing attendance by physician
Time frame: 2 weeks
during in-patient stay
1 secondary outcome
suicide
Time frame: 2 years after discharge
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 21 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Randolf Terje Vågen study director
St Olavs Hospital, Division of Mental Health Care
Nanna Sønnichsen Kayed study director
Department of Mental Health, Faculty of Medicine and Health, NTNU
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 St. Olavs Hospital 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 2 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 21 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?
self-inflicted, potentially injurious behavior with intention to die defined as acts needing attendance by physician (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2024; AzTrials last refreshed its copy on 27 Oct 2026.