Psychotic DisordersPhase 3FASTNCT00486798
FAST-A Study to Evaluate the Efficacy and Safety of Quetiapin IR in Patients With Acute Psychosis
A Phase 3 study testing Quetiapine, Rating Scales and Self Assessment Form in people with Psychotic Disorders and Schizophrenia, run by AstraZeneca at 13 sites in Sweden.
Trial summary
The purpose of this study is to compare the efficacy of quetiapine IR, following rapid titration versus conventional titration in patients with acute psychosis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychotic Disorders, Schizophrenia, Bipolar Disorder
- What is being tested?
- Quetiapine, Rating Scales and Self Assessment Form
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 13 sitesSweden
- Study dates
- May 2007to Aug 2007
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- provision of written informed consent
- male or female, aged 18-65 years
- requirement of hospitalization and in need for antipsychotic treatment for an acute psychotic episode
- able to swallow tablets from Day 1
Who cannot join
- In-patients who are anticipated to be discharged before evaluation of the primary outcome variable at Day 5
- patients with known relevant clinical disease
- history of syncope, or orthostatic hypotension
- patients with known neutropenia
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Sweden13 sites
Research Site
Borås
Research Site
Danderyd
Research Site
Falköping
Research Site
Gothenburg
Research Site
Karlskrona
Research Site
Malmö
Research Site
Öjebyn
Research Site
Piteå
Research Site
Simrishamn
Research Site
Stockholm
Research Site
Trollhättan
Research Site
Västerås
Research Site
Vaxjo
About this study
The purpose of this study is to compare the efficacy of quetiapine IR, following rapid titration versus conventional titration in patients with acute psychosis
- Conditions
- Psychotic Disorders, Schizophrenia, Bipolar Disorder
- Being tested
- Quetiapine, Rating Scales, Self Assessment Form, Blood and urine samples, Sleeping pattern
- Keywords
- acute schizophrenia, schizoaffective disorder, psychosis Not Otherwise Specified (NOS), bipolar mania with psychotic symptoms
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
Rating ScalesProcedure or surgery
Self Assessment FormProcedure or surgery
Blood and urine samplesProcedure or surgery
Sleeping patternProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Positive and Negative Syndrome Scale-Excitatory Subscale (PANSS-EC) at day 5 compared with baseline at day 1
Secondary outcomes (1)
Assessment of PANSS-EC at Day 3 and 8. Clinical Global Impression (CGI) at baseline and at Day 5 and 8. FAST (For Acute Seroquel Therapy) rating scale at baseline and at Day 5 and 8. The sleeping pattern (8days). Withdrawals/treatment failures. AE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionAug 2007
- Study completionAug 2007
Why it stopped: study was not ethically acceptable to continue and therefore it was finally stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jaan Ruusa, MD,PhD, Principal investigator, Huddinge Hospital Stockholm SwedenBirgit Ekholm, MD, Study director, AstraZeneca Sweden AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486798
- Sponsor's protocol ID
- D1443L00009
- Other IDs
- EUDRAC No. 2006-006426-26
- Acronym
- FAST
- Status last verified
- Apr 2009
- First submitted
- 14 Jun 2007
- Last updated
- 10 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAST-A Study to Evaluate the Efficacy and Safety of Quetiapin IR in Patients With Acute Psychosis
- ClinicalTrials.gov ID
- NCT00486798
- Acronym / sponsor ID
- FAST / D1443L00009
- Conditions
- Psychotic Disorders, Schizophrenia, Bipolar Disorder
- Keywords
- acute schizophrenia, schizoaffective disorder, psychosis Not Otherwise Specified (NOS), bipolar mania with psychotic symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study was not ethically acceptable to continue and therefore it was finally stopped
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 15 Jun 2007 (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 study is to compare the efficacy of quetiapine IR, following rapid titration versus conventional titration in patients with acute psychosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- provision of written informed consent
- male or female, aged 18-65 years
- requirement of hospitalization and in need for antipsychotic treatment for an acute psychotic episode
- able to swallow tablets from Day 1
Key exclusion criteria (4 listed)
- In-patients who are anticipated to be discharged before evaluation of the primary outcome variable at Day 5
- patients with known relevant clinical disease
- history of syncope, or orthostatic hypotension
- patients with known neutropenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quetiapine | Drug | – |
| Rating Scales | Procedure or surgery | – |
| Self Assessment Form | Procedure or surgery | – |
| Blood and urine samples | Procedure or surgery | – |
| Sleeping pattern | Procedure or surgery | – |
Primary outcome
Assessment of Positive and Negative Syndrome Scale-Excitatory Subscale (PANSS-EC) at day 5 compared with baseline at day 1
1 secondary outcome
Assessment of PANSS-EC at Day 3 and 8. Clinical Global Impression (CGI) at baseline and at Day 5 and 8. FAST (For Acute Seroquel Therapy) rating scale at baseline and at Day 5 and 8. The sleeping pattern (8days). Withdrawals/treatment failures. AE
Results and safety
The study was stopped early (reason given: study was not ethically acceptable to continue and therefore it was finally stopped). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2010.
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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.
Jaan Ruusa, MD,PhD principal investigator
Huddinge Hospital Stockholm Sweden
Birgit Ekholm, MD study director
AstraZeneca Sweden AB
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quetiapine, Rating Scales and Self Assessment Form in people with Psychotic Disorders and Schizophrenia, run by AstraZeneca at 13 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 10 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: study was not ethically acceptable to continue and therefore it was finally stopped). Results are not available in the source record.
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?
Assessment of Positive and Negative Syndrome Scale-Excitatory Subscale (PANSS-EC) at day 5 compared with baseline at day 1. 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 10 Dec 2010.