Seroquel in Bipolar Depression Versus Lithium
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)
2 other identifiers
interventional
672
16 countries
76
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2005
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedJanuary 4, 2013
January 1, 2013
September 13, 2005
January 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (76)
Research Site
Kelowna, British Columbia, Canada
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Sydney, Nova Scotia, Canada
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Greater Sudbury, Ontario, Canada
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Markham, Ontario, Canada
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Mississauga, Ontario, Canada
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Orléans, Ontario, Canada
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Waterloo, Ontario, Canada
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Montreal, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Osijek, Croatia
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Split, Croatia
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Zadar, Croatia
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Zagreb-Susedgrad, Croatia
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Kohtla-Järve, Estonia
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Tallinn, Estonia
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Tartu, Estonia
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Berlin, Germany
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Würzburg, Germany
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Solo, Java, Indonesia
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Jakarta, Indonesia
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Lawang, Indonesia
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Daugavpils, Latvia
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Riga, Latvia
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Kaunas, Lithuania
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Šiauliai, Lithuania
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Vilnius, Lithuania
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Kuala Lumpur, Malaysia
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Kuching Sarawak, Malaysia
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Petaling Jaya, Malaysia
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Brattvåg, Norway
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Drammen, Norway
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Fredrikstad, Norway
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Mysen, Norway
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Paradis, Norway
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Davao City, Philippines
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Iloilo City, Philippines
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Mandaluyong, Philippines
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Manila, Philippines
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Bialystok, Poland
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Bydgoszcz, Poland
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Gdynia, Poland
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Leszno, Poland
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Lodz, Poland
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Skorzewo, Poland
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Wroclaw, Poland
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Zabrze, Poland
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Arkhangelsk, Russia
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Kazan', Russia
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Lipetsk, Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Rostov-on-Don, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Smolensk, Russia
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Stavropol, Russia
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Tver', Russia
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Yaroslavl, Russia
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Belgrade, Serbia
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Čačak, Serbia
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Kragujevac, Serbia
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Niš, Serbia
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Valjevo, Serbia
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Gyeonggi-do, South Korea
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Seoul, South Korea
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Changhua, Taiwan
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Taipei, Taiwan
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Luhansk, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Simferopol, Ukraine
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Vinnitsa, Ukraine
Related Publications (1)
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.
PMID: 20122369DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Seroquel Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
August 1, 2005
Study Completion
May 1, 2007
Last Updated
January 4, 2013
Record last verified: 2013-01