Bipolar DisorderPhase 3NCT00206141
Seroquel in Bipolar Depression Versus Lithium
A Phase 3 study testing Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood) in people with Bipolar Disorder and Bipolar Depression, run by AstraZeneca at 76 sites in 16 countries.
Trial summary
This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in treating bipolar depression during an 8-week acute phase compared with placebo and lithium, followed by continuation treatment for 26 up to 52 with quetiapine fumarate (Seroquel) compared to placebo. 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™) drug, mood stabilizer (mood)
- How many people
- 672 participants
- Where
- 76 sitesin 16 countries
- Study dates
- Aug 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
- Patients with a diagnosis of bipolar I disorder or bipolar II disorder, currently depressed, aged 18 to 65 years old and outpatient status at enrolment and randomization.
Who cannot join
- Patients with a current DSM-IV Axis I disorder other than bipolar disorder that is symptomatic or requiring treatment within 6 months of enrolment,
- History of non-response to an adequate treatment
- Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk
- Pregnancy or lactation
- Clinically relevant disease or clinical finding
Trial locations and contacts
76 sites in 16 countries.
76 sites in 16 countries
Russia12 sites
Research Site
Arkhangelsk
Research Site
Kazan'
Research Site
Lipetsk
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Rostov-on-Don
Research Site
Saint Petersburg
Research Site
Saratov
Research Site
Smolensk
Research Site
Stavropol
Research Site
Tver'
Research Site
Yaroslavl
Canada9 sites
Research Site
Greater Sudbury, Ontario
Research Site
Kelowna, British Columbia
Research Site
Markham, Ontario
Research Site
Mississauga, Ontario
Research Site
Montreal, Quebec
Research Site
Orléans, Ontario
Research Site
Sherbrooke, Quebec
Research Site
Sydney, Nova Scotia
Research Site
Waterloo, Ontario
Ukraine9 sites
Research Site
Dnipropetrovsk
Research Site
Donetsk
Research Site
Kharkiv
Research Site
Kiev
Research Site
Luhansk
Research Site
Lviv
Research Site
Odesa
Research Site
Simferopol
Research Site
Vinnitsa
Poland8 sites
Research Site
Bialystok
Research Site
Bydgoszcz
Research Site
Gdynia
Research Site
Leszno
Research Site
Lodz
Research Site
Skorzewo
Research Site
Wroclaw
Research Site
Zabrze
Norway5 sites
Research Site
Brattvåg
Research Site
Drammen
Research Site
Fredrikstad
Research Site
Mysen
Research Site
Paradis
Serbia5 sites
Research Site
Belgrade
Research Site
Čačak
Research Site
Kragujevac
Research Site
Niš
Research Site
Valjevo
Croatia4 sites
Research Site
Osijek
Research Site
Split
Research Site
Zadar
Research Site
Zagreb-Susedgrad
Philippines4 sites
Research Site
Davao City
Research Site
Iloilo City
Research Site
Mandaluyong
Research Site
Manila
Estonia3 sites
Research Site
Kohtla-Järve
Research Site
Tallinn
Research Site
Tartu
Indonesia3 sites
Research Site
Jakarta
Research Site
Lawang
Research Site
Solo, Java
Lithuania3 sites
Research Site
Kaunas
Research Site
Šiauliai
Research Site
Vilnius
Malaysia3 sites
Research Site
Kuala Lumpur
Research Site
Kuching Sarawak
Research Site
Petaling Jaya
About this study
Official title: Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Lithium as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbreviated)
This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in treating bipolar depression during an 8-week acute phase compared with placebo and lithium, followed by continuation treatment for 26 up to 52 with quetiapine fumarate (Seroquel) compared to placebo.
- Conditions
- Bipolar Disorder, Bipolar Depression, Depression
- Being tested
- Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)
- 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, mood stabilizer (mood)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from randomization to Week 8 assessment in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
Secondary outcomes (2)
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 posted21 Sep 2005 (estimated)
- Study startAug 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
- 672 participants
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
- NCT00206141
- Sponsor's protocol ID
- D1447C00001
- Other IDs
- EMBOLDEN I
- Status last verified
- Jan 2013
- First submitted
- 13 Sep 2005
- Last updated
- 4 Jan 2013
- Results posted
- No
Publications
Young AH, McElroy SL, Bauer M, Philips N, Chang W, Olausson B, Paulsson B, Brecher M; EMBOLDEN I (Trial 001) Investigators. A double-blind, placebo-controlled study of quetiapine and lithium monotherapy in adults in the acute phase of bipolar depression (EMBOLDEN I). J Clin Psychiatry. 2010 Feb;71(2):150-62. doi: 10.4088/JCP.08m04995gre. Epub 2010 Jan 26.
PubMed 20122369
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
- Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Lithium as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbreviated)
- ClinicalTrials.gov ID
- NCT00206141
- Acronym / sponsor ID
- D1447C00001
- Conditions
- Bipolar Disorder, Bipolar Depression, Depression
- Keywords
- Bipolar disorder, bipolar depression, depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 672 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Study completion
- May 2007 (actual)
- First posted
- 21 Sep 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.
This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in treating bipolar depression during an 8-week acute phase compared with placebo and lithium, followed by continuation treatment for 26 up to 52 with quetiapine fumarate (Seroquel) compared to placebo.
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 (1 listed)
- Patients with a diagnosis of bipolar I disorder or bipolar II disorder, currently depressed, aged 18 to 65 years old and outpatient status at enrolment and randomization.
Key exclusion criteria (5 listed)
- Patients with a current DSM-IV Axis I disorder other than bipolar disorder that is symptomatic or requiring treatment within 6 months of enrolment,
- History of non-response to an adequate treatment
- Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk
- Pregnancy or lactation
- Clinically relevant disease or clinical finding
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, mood stabilizer (mood) | Drug | – |
Primary outcome
The change from randomization to Week 8 assessment in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
2 secondary outcomes
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 20122369Young AH, McElroy SL, Bauer M, Philips N, Chang W, Olausson B, Paulsson B, Brecher M; EMBOLDEN I (Trial 001) Investigators. A double-blind, placebo-controlled study of quetiapine and lithium monotherapy in adults in the acute phase of bipolar depression (EMBOLDEN I). J Clin Psychiatry. 2010 Feb;71(2):150-62. doi: 10.4088/JCP.08m04995gre. 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
76 sites in 16 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™) drug, mood stabilizer (mood) in people with Bipolar Disorder and Bipolar Depression, run by AstraZeneca at 76 sites in 16 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 1 inclusion and 5 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 76 sites in Russia, Canada, Ukraine, Poland, Norway and 11 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?
The change from randomization to Week 8 assessment in the Montgomery-Åsberg Depression Rating Scale (MADRS) 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 NCT00206141, 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.