Affective Psychosis, BipolarPhase 3NCT00422214
Phase III/Seroquel SR Bipolar Depression Monotherapy - US
A Phase 3 study testing Quetiapine fumarate (Seroquel) SR in people with Affective Psychosis, Bipolar and Depression, Bipolar, run by AstraZeneca at 54 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 Depression for 8 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, Depression, Bipolar, Manic-Depressive Psychosis
- What is being tested?
- Quetiapine fumarate (Seroquel) SR
- How many people
- 400 participants
- Where
- 54 sitesUnited States
- Study dates
- Dec 2006to 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 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 1 disorder or Bipolar 11 disorder
- Outpatient status at enrollment
Who cannot join
- Patients with >8 mood episodes during the past 12 years
- Use of prohibited medications
- Substance or alcohol abuse or dependence
- Current suicide risk or suicide attempt within last 6 months.
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
United States54 sites
Research Site
Beachwood, Ohio
Research Site
Bellevue, Washington
Research Site
Birmingham, Alabama
Research Site
Bradenton, Florida
Research Site
Brooklyn, New York
Research Site
Cerritos, California
Research Site
Charleston, South Carolina
Research Site
Charlottesville, Virginia
Research Site
Cherry Hill, New Jersey
Research Site
Cincinnati, Ohio
Research Site
Clementon, New Jersey
Research Site
Dallas, Texas
Research Site
Dayton, Ohio
Research Site
Farmington Hills, Michigan
Research Site
Fort Lauderdale, Florida
Research Site
Greenwood, Indiana
Research Site
Honolulu, Hawaii
Research Site
Houston, Texas
Research Site
Indianapolis, Indiana
Research Site
Jacksonville, Florida
Research Site
Joliet, Illinois
Research Site
La Mesa, California
Research Site
Leesburg, Florida
Research Site
Little Rock, Arkansas
Research Site
Los Angeles, California
Research Site
Maitland, Florida
Research Site
Memphis, Tennessee
Research Site
New York, New York
Research Site
Newport Beach, California
Research Site
North Miami, Florida
Research Site
Northridge, California
Research Site
Oceanside, California
Research Site
Oklahoma City, Oklahoma
Research Site
Orlando, Florida
Research Site
Philadelphia, Pennsylvania
Research Site
Phoenix, Arizona
Research Site
Pico Rivera, California
Research Site
Portland, Oregon
Research Site
Rockville, Maryland
Research Site
Salem, Oregon
Research Site
San Diego, California
Research Site
Scottsdale, Arizona
Research Site
Seattle, Washington
Research Site
Shreveport, Louisiana
Research Site
Smyrna, Georgia
Research Site
South Kirkland, Washington
Research Site
St Louis, Missouri
Research Site
Staten Island, New York
Research Site
Tampa, Florida
Research Site
Virginia Beach, Virginia
Research Site
Washington D.C., District of Columbia
Research Site
West Palm Beach, Florida
Research Site
Wichita, Kansas
Research Site
Wildomar, California
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 SR®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Depression
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 Depression for 8 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, Depression, Bipolar, Manic-Depressive Psychosis, Psychoses, Manic-Depressive
- Being tested
- Quetiapine fumarate (Seroquel) SR
- Keywords
- Bipolar Disorder, Bipolar Depression,, Manic Depression, Seroquel, Seroquel SR, quetiapine fumarate
- 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 fumarate (Seroquel) SRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in depression symptoms by final visit as measured by the MADRS total score
Secondary outcomes (1)
Change from baseline to final visit on the MADRS total score MADRS item scores, CGI-BP-S, CGI-BP-C
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 startDec 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 400 participants
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
- NCT00422214
- Sponsor's protocol ID
- D144CC00002
- Status last verified
- Mar 2009
- First submitted
- 12 Jan 2007
- Last updated
- 25 Mar 2009
- Results posted
- No
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 SR®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Depression
- ClinicalTrials.gov ID
- NCT00422214
- Acronym / sponsor ID
- D144CC00002
- Conditions
- Affective Psychosis, Bipolar, Depression, Bipolar, Manic-Depressive Psychosis, Psychoses, Manic-Depressive
- Keywords
- Bipolar Disorder, Bipolar Depression,, Manic Depression, Seroquel, Seroquel SR, quetiapine fumarate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Study completion
- Jun 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 Depression for 8 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 1 disorder or Bipolar 11 disorder
- Outpatient status at enrollment
Key exclusion criteria (4 listed)
- Patients with >8 mood episodes during the past 12 years
- Use of prohibited medications
- 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 in depression symptoms by final visit as measured by the MADRS total score
1 secondary outcome
Change from baseline to final visit on the MADRS total score MADRS item scores, CGI-BP-S, CGI-BP-C
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.
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
54 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 Depression, Bipolar, run by AstraZeneca at 54 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 54 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 in depression symptoms by final visit as measured by the MADRS total score. 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 25 Mar 2009.