Acute Psychotic SymptomsFAST-ONCT00913731
Quality Project to Evaluate and Validate the FAST-O Rating Scale
An observational study of Acute Psychotic Symptoms, run by AstraZeneca at 5 sites in Sweden.
Trial summary
The purpose of this project is to test the reliability of the FAST-O Rating Scale in patients at acute wards or psychiatric intensive care units. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Psychotic Symptoms
- How many people
- 111 participants
- Where
- 5 sitesSweden
- Study dates
- May 2009to Oct 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with acute psychotic symptoms attending the acute ward or psychiatric intensive care unit
Who may be able to join
- Patients with acute psychotic symptoms attending the acute ward or psychiatric intensive care unit
Who cannot join
- Not applicable
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites
Research Site
Helsingborg
Research Site
Kristianstad
Research Site
Lund
Research Site
Malmö
Research Site
Ystad
About this study
Official title: Quality Project to Evaluate and Validate the FAST-O Rating Scale (Fast ASessment in Acute Treatment of Psychosis-Observation)
The purpose of this project is to test the reliability of the FAST-O Rating Scale in patients at acute wards or psychiatric intensive care units.
- Conditions
- Acute Psychotic Symptoms
- Keywords
- Psychotic symptom assessments, Observational assessments of patients with acute psychotic symptoms
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 |
|---|---|---|
| psychotic patients | psychotic patients, acute ward, symptom rating scale. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability test of the FAST-O rating scale based on observational symptom ratings of patients with acute psychotic diseases
Measured: Each patients symtoms will be rated on 2 occasions, by 2-3 raters, each. First is made within 24 hrs of admission to acute psychiatric care, secondis made 14 +/- 2 days after admittance, or earlier if the patient is discharged.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startMay 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Psychotic SymptomsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eva Dencker Vansvik, Study director, Medical DepartmentEva Lindström, Principal investigator, Rättspsyk, UMAS, Malmö
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913731
- Sponsor's protocol ID
- NIS-NSE-DUM-2008/1
- Acronym
- FAST-O
- Status last verified
- Oct 2009
- First submitted
- 2 Jun 2009
- Last updated
- 29 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Project to Evaluate and Validate the FAST-O Rating Scale (Fast ASessment in Acute Treatment of Psychosis-Observation)
- ClinicalTrials.gov ID
- NCT00913731
- Acronym / sponsor ID
- FAST-O / NIS-NSE-DUM-2008/1
- Conditions
- Acute Psychotic Symptoms
- Keywords
- Psychotic symptom assessments, Observational assessments of patients with acute psychotic symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Study completion
- Oct 2009 (actual)
- First posted
- 4 Jun 2009 (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.
The purpose of this project is to test the reliability of the FAST-O Rating Scale in patients at acute wards or psychiatric intensive care units.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| psychotic patients | – | –psychotic patients, acute ward, symptom rating scale. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with acute psychotic symptoms attending the acute ward or psychiatric intensive care unit
Key inclusion criteria (1 listed)
- Patients with acute psychotic symptoms attending the acute ward or psychiatric intensive care unit
Key exclusion criteria (1 listed)
- Not applicable
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
Reliability test of the FAST-O rating scale based on observational symptom ratings of patients with acute psychotic diseases
Time frame: Each patients symtoms will be rated on 2 occasions, by 2-3 raters, each. First is made within 24 hrs of admission to acute psychiatric care, secondis made 14 +/- 2 days after admittance, or earlier if the patient is discharged.
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 29 Oct 2009.
Related trials for Acute Psychotic Symptoms
RecruitingObservational study
Immune Mechanisms of Antipsychotic Treatment Response
Psychosis
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.
Eva Dencker Vansvik study director
Medical Department
Eva Lindström principal investigator
Rättspsyk, UMAS, Malmö
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Psychotic Symptoms, run by AstraZeneca at 5 sites in Sweden.
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 1 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 29 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. 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?
Reliability test of the FAST-O rating scale based on observational symptom ratings of patients with acute psychotic diseases (time frame: Each patients symtoms will be rated on 2 occasions, by 2-3 raters, each. First is made within 24 hrs of admission to acute psychiatric care, secondis made 14 +/- 2 days after admittance, or earlier if the patient is discharged.). 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 29 Oct 2009.