Bipolar DisorderPhase 3EMBOLDEN IINCT00119652
Seroquel in Bipolar Depression Versus SSRI
A Phase 3 study testing quetiapine fumarate (Seroquel), paroxetine and mood stabilizing activity in people with Bipolar Disorder and Bipolar Depression, run by AstraZeneca at 55 sites in 11 countries.
Trial summary
The purpose of this study is to determine whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is continued. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Bipolar Depression, Depression
- What is being tested?
- quetiapine fumarate (Seroquel), paroxetine and mood stabilizing activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 676 participants
- Where
- 55 sitesin 11 countries
- Study dates
- May 2005to May 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
- Male and female out-patients aged 18 to 65 years inclusive
- Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II), most recent episode depressed
Who cannot join
- Current period of depression lasting less than 4 weeks or more than 12 months
- Use of prohibited medication
- Substance or alcohol dependence or abuse
- Current suicide risk or suicide attempt within 6 months
- Breast feeding or pregnancy
- Clinically relevant disease or clinical finding
Trial locations and contacts
55 sites in 11 countries.
55 sites in 11 countries
United States28 sites
Research Site
Atlanta, Georgia
Research Site
Austin, Texas
Research Site
Bellevue, Washington
Research Site
Cincinnati, Ohio
Research Site
Clementon, New Jersey
Research Site
Dallas, Texas
Research Site
Dayton, Ohio
Research Site
Glen Burnie, Maryland
Research Site
Irving, Texas
Research Site
Kirkland, Washington
Research Site
Little Rock, Arkansas
Research Site
Maitland, Florida
Research Site
National City, California
Research Site
New Orleans, Louisiana
Research Site
New York, New York
Research Site
Northfield, Illinois
Research Site
Oak Brook, Illinois
Research Site
Oklahoma City, Oklahoma
Research Site
Philadelphia, Pennsylvania
Research Site
Phoenix, Arizona
Research Site
Raleigh, North Carolina
Research Site
Richmond, Virginia
Research Site
San Clemente, California
Research Site
San Diego, California
Research Site
Shreveport, Louisiana
Research Site
Smyrna, Georgia
Research Site
St Louis, Missouri
Research Site
Winter Park, Florida
Australia5 sites
Research Site
Brisbane, Queensland
Research Site
Epping, Victoria
Research Site
Everton Park, Queensland
Research Site
Malvern, Victoria
Research Site
Southport, Queensland
Romania4 sites
Research Site
Bucharest
Research Site
Galati
Research Site
Iași
Research Site
Măgura
South Africa4 sites
Research Site
Benoni
Research Site
Cape Town
Research Site
Durban
Research Site
Pretoria
Greece3 sites
Research Site
Athens
Research Site
Thessaloniki
Research Site
Tripoli
Turkey (Türkiye)3 sites
Research Site
Gaziantep
Research Site
Istanbul
Research Site
Manisa
About this study
Official title: Multicentre, Double-blind, Randomised, Parallel Group, Placebo Controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Paroxetine as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbreviated)
The purpose of this study is to determine whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is continued.
- Conditions
- Bipolar Disorder, Bipolar Depression, Depression
- Being tested
- quetiapine fumarate (Seroquel), paroxetine, mood stabilizing activity
- Keywords
- Bipolar disorder, bipolar depression, depression
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quetiapine fumarate (Seroquel)Drug
paroxetineDrug
mood stabilizing activityBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Week 8 assessment in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS)
Secondary outcomes (3)
Secondary variables supportive to the primary objective:
MADRS total score response
MADRS total score remission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2005 (estimated)
- Study startMay 2005
- Study completionMay 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 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
- 676 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Seroquel Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119652
- Sponsor's protocol ID
- D1447C00134
- Acronym
- EMBOLDEN II
- Status last verified
- Jan 2013
- First submitted
- 6 Jul 2005
- Last updated
- 4 Jan 2013
- Results posted
- No
Publications
McElroy SL, Weisler RH, Chang W, Olausson B, Paulsson B, Brecher M, Agambaram V, Merideth C, Nordenhem A, Young AH; EMBOLDEN II (Trial D1447C00134) Investigators. A double-blind, placebo-controlled study of quetiapine and paroxetine as monotherapy in adults with bipolar depression (EMBOLDEN II). J Clin Psychiatry. 2010 Feb;71(2):163-74. doi: 10.4088/JCP.08m04942gre. Epub 2010 Jan 26.
PubMed 20122366
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
- Multicentre, Double-blind, Randomised, Parallel Group, Placebo Controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Paroxetine as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbreviated)
- ClinicalTrials.gov ID
- NCT00119652
- Acronym / sponsor ID
- EMBOLDEN II / D1447C00134
- Conditions
- Bipolar Disorder, Bipolar Depression, Depression
- Keywords
- Bipolar disorder, bipolar depression, depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 676 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- May 2007 (actual)
- First posted
- 14 Jul 2005 (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 whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is continued.
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 (2 listed)
- Male and female out-patients aged 18 to 65 years inclusive
- Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II), most recent episode depressed
Key exclusion criteria (6 listed)
- Current period of depression lasting less than 4 weeks or more than 12 months
- Use of prohibited medication
- Substance or alcohol dependence or abuse
- Current suicide risk or suicide attempt within 6 months
- Breast feeding or pregnancy
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) | Drug | – |
| paroxetine | Drug | – |
| mood stabilizing activity | Behavioural | – |
Primary outcome
Change from baseline to Week 8 assessment in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS)
3 secondary outcomes
Secondary variables supportive to the primary objective:
MADRS total score response
MADRS total score remission
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 20122366McElroy SL, Weisler RH, Chang W, Olausson B, Paulsson B, Brecher M, Agambaram V, Merideth C, Nordenhem A, Young AH; EMBOLDEN II (Trial D1447C00134) Investigators. A double-blind, placebo-controlled study of quetiapine and paroxetine as monotherapy in adults with bipolar depression (EMBOLDEN II). J Clin Psychiatry. 2010 Feb;71(2):163-74. doi: 10.4088/JCP.08m04942gre. Epub 2010 Jan 26.
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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.
AstraZeneca Seroquel Medical Science Director, MD study director
AstraZeneca
55 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing quetiapine fumarate (Seroquel), paroxetine and mood stabilizing activity in people with Bipolar Disorder and Bipolar Depression, run by AstraZeneca at 55 sites in 11 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 2 inclusion and 6 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 55 sites in United States, Australia, Romania, South Africa, Greece and 6 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?
Change from baseline to Week 8 assessment in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS). 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 NCT00119652, 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.