Bipolar DisorderPhase 3ANCHOR 149NCT00090311
Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children & Adolescents With Bipolar I Mania
A Phase 3 study testing quetiapine fumarate in people with Bipolar Disorder, run by AstraZeneca at 32 sites in United States.
Trial summary
The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of children and adolescent patients with Bipolar I mania. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- quetiapine fumarate
- How many people
- 220 participants
- Where
- 32 sitesUnited States
- Study dates
- Jul 2004to Jul 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 10 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 Bipolar I mania
- 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
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Research Site
Alamonte, Florida
Research Site
Augusta, Georgia
Research Site
Austin, Texas
Research Site
Bellevue, Washington
Research Site
Chapel Hill, North Carolina
Research Site
Chicago, Illinois
Research Site
Cincinnati, Ohio
Research Site
Clementon, New Jersey
Research Site
Cleveland, Ohio
Research Site
Denver, Colorado
Research Site
Houston, Texas
Research Site
Jacksonville, Florida
Research Site
Kirkland, Washington
Research Site
Las Vegas, Nevada
Research Site
Lyndhurst, Ohio
Research Site
Madison, Tennessee
Research Site
Miami, Florida
Research Site
Milwaukee, Wisconsin
Research Site
New Orleans, Louisiana
Research Site
Oklahoma City, Oklahoma
Research Site
Philadelphia, Pennsylvania
Research Site
Piscataway, New Jersey
Research Site
Richmond, Virginia
Research Site
Riverside, California
Research Site
Rochester, New York
Research Site
Sacramento, California
Research Site
Saint Charles, Missouri
Research Site
San Antonio, Texas
Research Site
San Diego, California
Research Site
Scottsdale, Arizona
Research Site
Virginia Beach, Virginia
Research Site
Wichita, Kansas
About this study
Official title: A 3-wk, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 3b Study of the Efficacy & Safety of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets in the Treatment of Children & Adolescents With Bipolar I Mania (Abbreviated)
The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of children and adolescent patients with Bipolar I mania.
- Conditions
- Bipolar Disorder
- Being tested
- quetiapine fumarate
- Keywords
- Bipolar I Mania
- Medical subject headings
- Bipolar Disorder
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.
Compare efficacy of Quetiapine with placebo in the treatment of bipolar I mania as assessed by the YMRS total score, change from baseline to Day 21
Secondary outcomes (1)
Compare the effect of Quetiapine with placebo in change from baseline to Day 21 percentage of patients with response, defined as a ≤ 12, 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 startJul 2004
- Study completionJul 2006
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 Bipolar DisorderStudies 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
- 220 participants (actual)
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
- NCT00090311
- Sponsor's protocol ID
- D1441C00149
- Acronym
- ANCHOR 149
- Status last verified
- Jan 2013
- First submitted
- 25 Aug 2004
- Last updated
- 4 Jan 2013
- Results posted
- No
Publications
Pathak S, Findling RL, Earley WR, Acevedo LD, Stankowski J, Delbello MP. Efficacy and safety of quetiapine in children and adolescents with mania associated with bipolar I disorder: a 3-week, double-blind, placebo-controlled trial. J Clin Psychiatry. 2013 Jan;74(1):e100-9. doi: 10.4088/JCP.11m07424.
PubMed 23419231
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 3-wk, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 3b Study of the Efficacy & Safety of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets in the Treatment of Children & Adolescents With Bipolar I Mania (Abbreviated)
- ClinicalTrials.gov ID
- NCT00090311
- Acronym / sponsor ID
- ANCHOR 149 / D1441C00149
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar I Mania
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Jul 2006 (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 children and adolescent patients with Bipolar I mania.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 10 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 Bipolar I mania
- 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 | Drug | – |
Primary outcome
Compare efficacy of Quetiapine with placebo in the treatment of bipolar I mania as assessed by the YMRS total score, change from baseline to Day 21
1 secondary outcome
Compare the effect of Quetiapine with placebo in change from baseline to Day 21 percentage of patients with response, defined as a ≤ 12, 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 23419231Pathak S, Findling RL, Earley WR, Acevedo LD, Stankowski J, Delbello MP. Efficacy and safety of quetiapine in children and adolescents with mania associated with bipolar I disorder: a 3-week, double-blind, placebo-controlled trial. J Clin Psychiatry. 2013 Jan;74(1):e100-9. doi: 10.4088/JCP.11m07424.
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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
32 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 fumarate in people with Bipolar Disorder, run by AstraZeneca at 32 sites in United States.
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 32 sites in United States. 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 bipolar I mania as assessed by the YMRS total score, change from baseline to Day 21. 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 NCT00090311, 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.