SchizophreniaPhase 3RAPIDNCT00457899
Rapid Versus Conventional Titration of Quetiapine in Schizophrenia/Schizoaffective Disorder
A Phase 3 study testing Quetiapine IR (Immediate Release) in people with Schizophrenia and Schizoaffective Disorders, run by AstraZeneca at 12 sites in United Kingdom.
Trial summary
The purpose of this study is to determine whether increasing the amount (dose) of quetiapine IR (immediate release formulation) more rapidly than conventional dose increases, improves the control of symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) - a psychiatric assessment scale that measures… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorders, Psychotic Disorders
- What is being tested?
- Quetiapine IR (Immediate Release)
- Type of treatment
- Pill or oral medicine
- How many people
- 234 participants
- Where
- 12 sitesUnited Kingdom
- Study dates
- Jul 2007to Sep 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
- Men and women, aged 18 to 65 years, who require treatment for an acute episode of schizophrenia/schizoaffective disorder as judged by their doctor
Who cannot join
- Significant and unstable conditions of hear, circulation, blood, liver, kidney; malignancies (cancer); diabetes (mellitus); history of fits or fainting. Resistance to antipsychotic medication. Current alcohol/drug abuse. Pregnant/breast feeding women.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United Kingdom12 sites
Research Site
Birmingham
Research Site
Bognor Regis
Research Site
Brentwood, Essex
Research Site
Bury St Edmunds
Research Site
Coventry
Research Site
Crewe
Research Site
Darlington
Research Site
Harrow, Middlesex
Research Site
London
Research Site
Sandbach
Research Site
Surbiton, Surrey
Research Site
Warrington
About this study
Official title: RAPID-An Open-Label Randomized, Multicenter Phase IIIb Study to Evaluate the Efficacy and Tolerability of Quetiapine IR (Immediate Release), Over 14 Days, in Acute Schizophrenia/Schizoaffective Disorder (Rapid Versus Conventional Titration)
The purpose of this study is to determine whether increasing the amount (dose) of quetiapine IR (immediate release formulation) more rapidly than conventional dose increases, improves the control of symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) - a psychiatric assessment scale that measures both positive and negative symptoms - in patients with acute schizophrenia or schizoaffective disorder.
- Being tested
- Quetiapine IR (Immediate Release)
- Keywords
- schizophrenia, schizoaffective disorder, quetiapine, seroquel, titration
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine IR (Immediate Release)Drug
Also called Seroquel
oral
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome variable of this study is change from baseline in total PANSS score
Measured: at Day 7
Secondary outcomes (4)
Change from baseline in total PANSS scores
Measured: on day 5 and 14
change from baseline in CGI-S and absolute CGI-I
Measured: on days 5, 7 and 14
frequency and severity of adverse events; change in vital signs.
Measured: assessed at each visit
change from baseline in subscale PANSS and PANSS-EC scores
Measured: on days 5, 7 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2007 (estimated)
- Study startJul 2007
- Study completionSep 2007
Why it stopped: Study terminated due to poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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)
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca UK Medical Director, MD, Study director, AstraZeneca UKProfessor Gary Sullivan, MD, Principal investigator, St Tydfil's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457899
- Sponsor's protocol ID
- D1443L00003
- Acronym
- RAPID
- Status last verified
- Nov 2007
- First submitted
- 5 Apr 2007
- Last updated
- 27 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAPID-An Open-Label Randomized, Multicenter Phase IIIb Study to Evaluate the Efficacy and Tolerability of Quetiapine IR (Immediate Release), Over 14 Days, in Acute Schizophrenia/Schizoaffective Disorder (Rapid Versus Conventional Titration)
- ClinicalTrials.gov ID
- NCT00457899
- Acronym / sponsor ID
- RAPID / D1443L00003
- Keywords
- schizophrenia, schizoaffective disorder, quetiapine, seroquel, titration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to poor recruitment
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Study completion
- Sep 2007 (actual)
- First posted
- 9 Apr 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 determine whether increasing the amount (dose) of quetiapine IR (immediate release formulation) more rapidly than conventional dose increases, improves the control of symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) - a psychiatric assessment scale that measures both positive and negative symptoms - in patients with acute schizophrenia or schizoaffective disorder.
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 (1 listed)
- Men and women, aged 18 to 65 years, who require treatment for an acute episode of schizophrenia/schizoaffective disorder as judged by their doctor
Key exclusion criteria (1 listed)
- Significant and unstable conditions of hear, circulation, blood, liver, kidney; malignancies (cancer); diabetes (mellitus); history of fits or fainting. Resistance to antipsychotic medication. Current alcohol/drug abuse. Pregnant/breast feeding women.
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 IR (Immediate Release)Also: Seroqueloral | Drug | – |
Primary outcome
The primary outcome variable of this study is change from baseline in total PANSS score
Time frame: at Day 7
4 secondary outcomes
Change from baseline in total PANSS scores
Time frame: on day 5 and 14
change from baseline in CGI-S and absolute CGI-I
Time frame: on days 5, 7 and 14
frequency and severity of adverse events; change in vital signs.
Time frame: assessed at each visit
change from baseline in subscale PANSS and PANSS-EC scores
Time frame: on days 5, 7 and 14
Results and safety
The study was stopped early (reason given: Study terminated due to poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2007.
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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.
AstraZeneca UK Medical Director, MD study director
AstraZeneca UK
Professor Gary Sullivan, MD principal investigator
St Tydfil's Hospital
12 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 IR (Immediate Release) in people with Schizophrenia and Schizoaffective Disorders, run by AstraZeneca at 12 sites in United Kingdom.
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: stopped early, as of the sponsor's last update on 27 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom. 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 terminated due to poor recruitment). 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?
The primary outcome variable of this study is change from baseline in total PANSS score (time frame: at Day 7). 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 27 Nov 2007.