SchizophreniaPhase 3ANCHOR 112NCT00090324
Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Adolescent Patients With Schizophrenia
A Phase 3 study testing quetiapine fumarate tablets in people with Schizophrenia, run by AstraZeneca at 42 sites in 10 countries.
Trial summary
The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of adolescent patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- quetiapine fumarate tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 249 participants
- Where
- 42 sitesin 10 countries
- Study dates
- Sep 2004to Jun 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient is able to provide written assent and the parents or legal guardian of the patient is able to provide written informed consent before beginning and study related procedures
- Patient has a documented clinical diagnosis of schizophrenia
- Patient's parent or legal guardian will be able to accompany the patient at each scheduled study visit
Who cannot join
- Patients (female) must not be pregnant or lactating
- Patients with a known intolerance or lack of response to previous treatment with quetiapine
- Patients who have previously participated in this study
Trial locations and contacts
42 sites in 10 countries.
42 sites in 10 countries
United States23 sites
Research Site
Alamonte, Florida
Research Site
Cerritos, California
Research Site
Chicago, Illinois
Research Site
Cincinnati, Ohio
Research Site
Cleveland, Ohio
Research Site
Denver, Colorado
Research Site
Dothan, Alabama
Research Site
Jacksonville, Florida
Research Site
Kirkland, Washington
Research Site
Las Vegas, Nevada
Research Site
Lyndhurst, Ohio
Research Site
Memphis, Tennessee
Research Site
Miami, Florida
Research Site
Milwaukee, Wisconsin
Research Site
New Orleans, Louisiana
Research Site
Newton, Kansas
Research Site
Oak Brook, Illinois
Research Site
Oklahoma City, Oklahoma
Research Site
Richmond, Virginia
Research Site
Riverside, California
Research Site
Sacramento, California
Research Site
San Diego, California
Research Site
Virginia Beach, Virginia
Philippines4 sites
Research Site
Davao City
Research Site
Mandaluyong
Research Site
Manila
Research Site
Quezon City
About this study
Official title: A 6-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 3b Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets Compared With Placebo in Adolescents With Schizophrenia (Abbreviated)
The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of adolescent patients with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- quetiapine fumarate tablets
- 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.
quetiapine fumarate tabletsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare efficacy of Quetiapine with placebo in the treatment of schizophrenia as assessed by the PANSS total score, change from baseline to Day 42
Secondary outcomes (1)
Compare the effect of Quetiapine with placebo in change from baseline to Day 42 level of functioning, evaluate aggression and hostility; evaluate safety and tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2004 (estimated)
- Study startSep 2004
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Enrolment
- 249 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Seroquel Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090324
- Sponsor's protocol ID
- D1441C00112
- Acronym
- ANCHOR 112
- Status last verified
- Jan 2013
- First submitted
- 25 Aug 2004
- Last updated
- 4 Jan 2013
- Results posted
- No
Publications
Findling RL, McKenna K, Earley WR, Stankowski J, Pathak S. Efficacy and safety of quetiapine in adolescents with schizophrenia investigated in a 6-week, double-blind, placebo-controlled trial. J Child Adolesc Psychopharmacol. 2012 Oct;22(5):327-42. doi: 10.1089/cap.2011.0092.
PubMed 23083020
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 3b Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets Compared With Placebo in Adolescents With Schizophrenia (Abbreviated)
- ClinicalTrials.gov ID
- NCT00090324
- Acronym / sponsor ID
- ANCHOR 112 / D1441C00112
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Jun 2007 (actual)
- First posted
- 30 Aug 2004 (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 demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of adolescent patients with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patient is able to provide written assent and the parents or legal guardian of the patient is able to provide written informed consent before beginning and study related procedures
- Patient has a documented clinical diagnosis of schizophrenia
- Patient's parent or legal guardian will be able to accompany the patient at each scheduled study visit
Key exclusion criteria (3 listed)
- Patients (female) must not be pregnant or lactating
- Patients with a known intolerance or lack of response to previous treatment with quetiapine
- Patients who have previously participated in this study
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 tablets | Drug | – |
Primary outcome
Compare efficacy of Quetiapine with placebo in the treatment of schizophrenia as assessed by the PANSS total score, change from baseline to Day 42
1 secondary outcome
Compare the effect of Quetiapine with placebo in change from baseline to Day 42 level of functioning, evaluate aggression and hostility; evaluate safety and tolerability
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 4 Jan 2013.
- Derived from this study: PubMed 23083020Findling RL, McKenna K, Earley WR, Stankowski J, Pathak S. Efficacy and safety of quetiapine in adolescents with schizophrenia investigated in a 6-week, double-blind, placebo-controlled trial. J Child Adolesc Psychopharmacol. 2012 Oct;22(5):327-42. doi: 10.1089/cap.2011.0092.
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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.
Seroquel Medical Science Director, MD study director
AstraZeneca
42 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing quetiapine fumarate tablets in people with Schizophrenia, run by AstraZeneca at 42 sites in 10 countries.
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 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Philippines, Ukraine, India, Malaysia and 5 more countries. 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?
Compare efficacy of Quetiapine with placebo in the treatment of schizophrenia as assessed by the PANSS total score, change from baseline to Day 42. 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 NCT00090324, which also lists 1 linked publication.
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 4 Jan 2013.