Affective Psychosis, BipolarPhase 3NCT00422123
Phase 3 /Seroquel SR Acute Mania Monotherapy - US
A Phase 3 study testing Quetiapine fumarate (Seroquel) SR in people with Affective Psychosis, Bipolar and Manic Disorder, run by AstraZeneca at 51 sites in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Mania for 3 weeks. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Affective Psychosis, Bipolar, Manic Disorder, Manic-Depressive Psychosis
- What is being tested?
- Quetiapine fumarate (Seroquel) SR
- How many people
- 447 participants
- Where
- 51 sitesUnited States
- Study dates
- Jan 2007to Jul 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
- Provision of written informed consent
- Documented diagnosis of Bipolar Disorder, with most recent episode being manic or mixed
- Inpatient hospital admission for the first 4 days of study treatment
Who cannot join
- >8 mood episodes within the last 12 months
- Use of prohibited medication
- Substance or alcohol abuse or dependence
- Current suicide risk or suicide attempt within last 6 months.
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
United States51 sites
Research Site
Arlington, Virginia
Research Site
Atlanta, Georgia
Research Site
Austin, Texas
Research Site
Aventura, Florida
Research Site
Beachwood, Ohio
Research Site
Bellevue, Washington
Research Site
Cerritos, California
Research Site
Charleston, South Carolina
Research Site
Denver, Colorado
Research Site
DeSoto, Texas
Research Site
Durham, North Carolina
Research Site
EAST Bradenton, Florida
Research Site
Elmsford, New York
Research Sitew
Fort Lauderdale, Florida
Research Site
Garden Grove, California
Research Site
Greenwood, Indiana
Research Site
Hoffman Estates, Illinois
Research Site
Holliswood, New York
Research Site
Hollywood, Florida
Research Site
Honolulu, Hawaii
Research Site
Houston, Texas
Research Site
Indianapolis, Indiana
Research Site
Irving, Texas
Research Site
Kenilworth, New Jersey
Research Site
Lake Charles, Louisiana
Research Site
Leesburg, Florida
Research Site
Little Rock, Arkansas
Research Site
Memphis, Tennessee
Research Site
Moon Township, Pennsylvania
Research Site
Naperville, Illinois
Research Site
Nashville, Tennessee
Research Site
New Orleans, Louisiana
Research Site
Newton, Kansas
Research Site
OAK Brook Terrace, Illinois
Research Site
Oceanside, California
Research Site
Oklahoma City, Oklahoma
Research Site
Philadelphia, Pennsylvania
Research Site
Phoenix, Arizona
Research Site
Pico Rivera, California
Research Site
Richmond, Virginia
Research Site
Rockville, Maryland
Research Site
San Antonio, Texas
Research Site
San Diego, California
Research Site
Santa Ana, California
Research Site
Shreveport, Louisiana
Research Site
St Louis, Missouri
Research Site
Tampa, Florida
Research Site
Torrance, California
Research Site
Washington D.C., District of Columbia
Research Site
Wichita, Kansas
Research Site
Willingboro, New Jersey
About this study
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Mania
The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Mania for 3 weeks.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
- Conditions
- Affective Psychosis, Bipolar, Manic Disorder, Manic-Depressive Psychosis, Mania, Manic State, Psychoses, Manic-Depressive
- Being tested
- Quetiapine fumarate (Seroquel) SR
- Keywords
- Bipolar Disorder, Bipolar Mania, Manic Depression, Seroquel, Seroquel SR, quetiapine fumarate
- Medical subject headings
- Bipolar Disorder, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine fumarate (Seroquel) SRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to final visit in the YMRS total score
Secondary outcomes (1)
Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2007 (estimated)
- Study startJan 2007
- Study completionJul 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 Affective Psychosis, BipolarStudies 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
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Catherine Datto, MD, Study director, AstraZenecaLarisa Acevedo, Ph.D, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422123
- Sponsor's protocol ID
- D144CC00004
- Status last verified
- Mar 2009
- First submitted
- 12 Jan 2007
- Last updated
- 25 Mar 2009
- Results posted
- No
Publications
Cutler AJ, Datto C, Nordenhem A, Minkwitz M, Acevedo L, Darko D. Extended-release quetiapine as monotherapy for the treatment of adults with acute mania: a randomized, double-blind, 3-week trial. Clin Ther. 2011 Nov;33(11):1643-58. doi: 10.1016/j.clinthera.2011.10.002. Epub 2011 Nov 4.
PubMed 22054797
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Mania
- ClinicalTrials.gov ID
- NCT00422123
- Acronym / sponsor ID
- D144CC00004
- Conditions
- Affective Psychosis, Bipolar, Manic Disorder, Manic-Depressive Psychosis, Mania, Manic State, Psychoses, Manic-Depressive
- Keywords
- Bipolar Disorder, Bipolar Mania, Manic Depression, Seroquel, Seroquel SR, quetiapine fumarate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Study completion
- Jul 2007 (actual)
- First posted
- 15 Jan 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 the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Mania for 3 weeks.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
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 (3 listed)
- Provision of written informed consent
- Documented diagnosis of Bipolar Disorder, with most recent episode being manic or mixed
- Inpatient hospital admission for the first 4 days of study treatment
Key exclusion criteria (4 listed)
- >8 mood episodes within the last 12 months
- Use of prohibited medication
- Substance or alcohol abuse or dependence
- Current suicide risk or suicide attempt within last 6 months.
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 (Seroquel) SR | Drug | – |
Primary outcome
Change from baseline to final visit in the YMRS total score
1 secondary outcome
Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS.
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 25 Mar 2009.
- Derived from this study: PubMed 22054797Cutler AJ, Datto C, Nordenhem A, Minkwitz M, Acevedo L, Darko D. Extended-release quetiapine as monotherapy for the treatment of adults with acute mania: a randomized, double-blind, 3-week trial. Clin Ther. 2011 Nov;33(11):1643-58. doi: 10.1016/j.clinthera.2011.10.002. Epub 2011 Nov 4.
Related trials for Affective Psychosis, Bipolar
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
RecruitingPhase 4
Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
Depression, Bipolar
Active, not recruiting
Functional Remediation for Older Adults With Bipolar Disorder
Bipolar Disorder
Recruiting
HD-tDCS for Adolescent Bipolar Depression Targeting S1
Adolescent, Bipolar Depression
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.
Catherine Datto, MD study director
AstraZeneca
Larisa Acevedo, Ph.D study director
AstraZeneca
51 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 (Seroquel) SR in people with Affective Psychosis, Bipolar and Manic Disorder, run by AstraZeneca at 51 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 4 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 25 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 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?
Change from baseline to final visit in the YMRS total score. 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 NCT00422123, 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 25 Mar 2009.