SchizophreniaPhase 2NCT00254787
Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in Acute Schizophrenic Patients
A Phase 2 study testing IR (Immediate-Release) quetiapine fumarate (drug) in people with Schizophrenia, run by AstraZeneca at 6 sites in Germany.
Trial summary
The purpose of the study is to compare the safety and tolerability of IR (Immediate-Release) quetiapine in a rapid escalation scheme with to the current approved label titration. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- IR (Immediate-Release) quetiapine fumarate (drug)
- How many people
- 30 participants
- Where
- 6 sitesGermany
- Study dates
- Jun 2005to Jan 2006
- Phase
- Phase 2
- 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 age ≥18 to ≤65 years with acute schizophrenia
- Provision of written informed consent prior to enrolment
Who cannot join
- Meeting the criteria for any other (than schizophrenia) psychotic disorder not in full remission, concomitant organic mental disorder or mental retardation
- Patients with substance dependence
- Female patients who are pregnant, lactating or at risk of pregnancy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Research Site
Berlin
Research Site
Cologne
Research Site
Essen
Research Site
Hamburg
Research Site
Jena
Research Site
Werneck
About this study
Official title: Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in the Treatment of Patients With Acute Schizophrenia - a Multicentre, Double-Blind, Parallel Group, Randomized Study
The purpose of the study is to compare the safety and tolerability of IR (Immediate-Release) quetiapine in a rapid escalation scheme with to the current approved label titration.
- Conditions
- Schizophrenia
- Being tested
- IR (Immediate-Release) quetiapine fumarate (drug)
- Keywords
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IR (Immediate-Release) quetiapine fumarate (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who discontinue the study treatment due to adverse events (AEs) during the first week (day 1 to day 7) of treatment
Secondary outcomes (6)
Safety and Tolerability
Number and type of adverse events
Changes in vital signs and weight
Clinically significant changes in ECG (reported as AE)
Change of Simpson-Angus Scale (SAS) score
Change of Barnes Akathisia Rating Scale (BARS) score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2005 (estimated)
- Study startJun 2005
- Study completionJan 2006
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Germany Medical Director, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254787
- Sponsor's protocol ID
- D1441L00032
- Other IDs
- RACE, EudraCT-No. 2004-005122-45
- Status last verified
- Jun 2009
- First submitted
- 15 Nov 2005
- Last updated
- 11 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in the Treatment of Patients With Acute Schizophrenia - a Multicentre, Double-Blind, Parallel Group, Randomized Study
- ClinicalTrials.gov ID
- NCT00254787
- Acronym / sponsor ID
- D1441L00032
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Study completion
- Jan 2006 (actual)
- First posted
- 17 Nov 2005 (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 the study is to compare the safety and tolerability of IR (Immediate-Release) quetiapine in a rapid escalation scheme with to the current approved label titration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women age ≥18 to ≤65 years with acute schizophrenia
- Provision of written informed consent prior to enrolment
Key exclusion criteria (3 listed)
- Meeting the criteria for any other (than schizophrenia) psychotic disorder not in full remission, concomitant organic mental disorder or mental retardation
- Patients with substance dependence
- Female patients who are pregnant, lactating or at risk of pregnancy
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 |
|---|---|---|
| IR (Immediate-Release) quetiapine fumarate (drug) | Drug | – |
Primary outcome
Proportion of patients who discontinue the study treatment due to adverse events (AEs) during the first week (day 1 to day 7) of treatment
6 secondary outcomes
Safety and Tolerability
Number and type of adverse events
Changes in vital signs and weight
Clinically significant changes in ECG (reported as AE)
Change of Simpson-Angus Scale (SAS) score
Change of Barnes Akathisia Rating Scale (BARS) score
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 11 Jun 2009.
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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 Germany Medical Director study director
AstraZeneca
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IR (Immediate-Release) quetiapine fumarate (drug) in people with Schizophrenia, run by AstraZeneca at 6 sites in Germany.
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 3 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 11 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Proportion of patients who discontinue the study treatment due to adverse events (AEs) during the first week (day 1 to day 7) of treatment. 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 11 Jun 2009.