PsychosisPhase 3NCT00449397
Dose Finding of Quetiapine Fumarate 200mg vs 400mg in First Episode Psychosis
A Phase 3 study testing Quetiapine Fumarate in people with Psychosis, run by AstraZeneca at 1 site in Australia.
Trial summary
The purpose of this study is determine the minimal effective dose and the impact on: 1. treatment outcomes at 4, 12 and/or 48 weeks the treatment has required to treat patients experiencing the first psychotic episode 2. the final maintenance doses 3. the use of other medications 4. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Quetiapine Fumarate
- How many people
- 150 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2003to Jan 2006
- 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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients experiencing their first psychotic episode
- Male or Female
- Aged 15-25
Who cannot join
- Previous treatment with antipsychotic medication (longer than 1 week)
- History of a clinically significant physical illness
- Organic disorder presenting with psychotic symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Naturalistic, Prospective, Single Centre, Double Blinded, Fixed Dose, Randomised, Four Week Comparison Study Investigating Efficacy, Tolerability and Safety of 200 mg Per Day Versus 400 mg Per Day Quetiapine Fumarate in 200 Drug naïve First Episode Psychosis Patients Aged 15 to 25 Years.
The purpose of this study is determine the minimal effective dose and the impact on:
- treatment outcomes at 4, 12 and/or 48 weeks the treatment has required to treat patients experiencing the first psychotic episode
- the final maintenance doses
- the use of other medications
- the amount of changes to other antipsychotic medication
- the number of hospitalization days
- Conditions
- Psychosis
- Being tested
- Quetiapine Fumarate
- Keywords
- First Episode Psychosis
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine FumarateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication dose, Remission and response rate, exBPRSvs4, SANS, CGI - I, CGI - S, CDSS, GAF and QoL scale
Secondary outcomes (1)
SWN, UKU, illicit substance use, laboratory measures, altered drop-out rates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2007 (estimated)
- Study startJul 2003
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies 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
- Single group
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gregor Berger, MD, Principal investigator, ORYGEN Research Centre/ ORYGEN Youth Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449397
- Sponsor's protocol ID
- AU-SEA-0003
- Status last verified
- Jan 2011
- First submitted
- 19 Mar 2007
- Last updated
- 27 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Hides L, Cotton SM, Berger G, Gleeson J, O'Donnell C, Proffitt T, McGorry PD, Lubman DI. The reliability and validity of the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) in first-episode psychosis. Addict Behav. 2009 Oct;34(10):821-5. doi: 10.1016/j.addbeh.2009.03.001. Epub 2009 Mar 6.
PubMed 19324499Berger GE, Proffitt TM, McConchie M, Kerr M, Markulev C, Yuen HP, O'Donnell C, Lubman D, Polari A, Wood S, Amminger PG, McGorry PD. Dosing quetiapine in drug-naive first-episode psychosis: a controlled, double-blind, randomized, single-center study investigating efficacy, tolerability, and safety of 200 mg/day vs. 400 mg/day of quetiapine fumarate in 141 patients aged 15 to 25 years. J Clin Psychiatry. 2008 Nov;69(11):1702-14. Epub 2008 Nov 18.
PubMed 19036233
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Naturalistic, Prospective, Single Centre, Double Blinded, Fixed Dose, Randomised, Four Week Comparison Study Investigating Efficacy, Tolerability and Safety of 200 mg Per Day Versus 400 mg Per Day Quetiapine Fumarate in 200 Drug naïve First Episode Psychosis Patients Aged 15 to 25 Years.
- ClinicalTrials.gov ID
- NCT00449397
- Acronym / sponsor ID
- AU-SEA-0003
- Conditions
- Psychosis
- Keywords
- First Episode Psychosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 20 Mar 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 determine the minimal effective dose and the impact on:
- treatment outcomes at 4, 12 and/or 48 weeks the treatment has required to treat patients experiencing the first psychotic episode
- the final maintenance doses
- the use of other medications
- the amount of changes to other antipsychotic medication
- the number of hospitalization days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients experiencing their first psychotic episode
- Male or Female
- Aged 15-25
Key exclusion criteria (3 listed)
- Previous treatment with antipsychotic medication (longer than 1 week)
- History of a clinically significant physical illness
- Organic disorder presenting with psychotic symptoms
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 Fumarate | Drug | – |
Primary outcome
Medication dose, Remission and response rate, exBPRSvs4, SANS, CGI - I, CGI - S, CDSS, GAF and QoL scale
1 secondary outcome
SWN, UKU, illicit substance use, laboratory measures, altered drop-out rates
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 27 Jan 2011.
- Derived from this study: PubMed 19324499Hides L, Cotton SM, Berger G, Gleeson J, O'Donnell C, Proffitt T, McGorry PD, Lubman DI. The reliability and validity of the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) in first-episode psychosis. Addict Behav. 2009 Oct;34(10):821-5. doi: 10.1016/j.addbeh.2009.03.001. Epub 2009 Mar 6.
- Derived from this study: PubMed 19036233Berger GE, Proffitt TM, McConchie M, Kerr M, Markulev C, Yuen HP, O'Donnell C, Lubman D, Polari A, Wood S, Amminger PG, McGorry PD. Dosing quetiapine in drug-naive first-episode psychosis: a controlled, double-blind, randomized, single-center study investigating efficacy, tolerability, and safety of 200 mg/day vs. 400 mg/day of quetiapine fumarate in 141 patients aged 15 to 25 years. J Clin Psychiatry. 2008 Nov;69(11):1702-14. Epub 2008 Nov 18.
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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.
Gregor Berger, MD principal investigator
ORYGEN Research Centre/ ORYGEN Youth Health
1 site 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 Fumarate in people with Psychosis, run by AstraZeneca at 1 site in Australia.
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 3 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 27 Jan 2011. 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 Australia. 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 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?
Medication dose, Remission and response rate, exBPRSvs4, SANS, CGI - I, CGI - S, CDSS, GAF and QoL scale. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00449397, which also lists 2 linked publications.
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 Jan 2011.