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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00119652




Registration number
NCT00119652
Ethics application status
Date submitted
6/07/2005
Date registered
14/07/2005
Date last updated
4/01/2013

Titles & IDs
Public title
Seroquel in Bipolar Depression Versus SSRI
Scientific 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)
Secondary ID [1] 0 0
D1447C00134
Universal Trial Number (UTN)
Trial acronym
EMBOLDEN II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder 0 0
Bipolar Depression 0 0
Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline to Week 8 assessment in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Secondary variables supportive to the primary objective:
Timepoint [1] 0 0
Secondary outcome [2] 0 0
MADRS total score response
Timepoint [2] 0 0
Secondary outcome [3] 0 0
MADRS total score remission
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
* Male and female out-patients aged 18 to 65 years inclusive
* Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II), most recent episode depressed
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2007
Sample size
Target
Accrual to date
Final
676
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Research Site - Brisbane
Recruitment hospital [2] 0 0
Research Site - Everton Park
Recruitment hospital [3] 0 0
Research Site - Southport
Recruitment hospital [4] 0 0
Research Site - Epping
Recruitment hospital [5] 0 0
Research Site - Malvern
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Everton Park
Recruitment postcode(s) [3] 0 0
- Southport
Recruitment postcode(s) [4] 0 0
- Epping
Recruitment postcode(s) [5] 0 0
- Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
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United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
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United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
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Missouri
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
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Washington
Country [19] 0 0
Chile
State/province [19] 0 0
Providencia Santiago
Country [20] 0 0
Chile
State/province [20] 0 0
Santiago
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Colombia
State/province [21] 0 0
Bogota
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Costa Rica
State/province [22] 0 0
San Jose
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Greece
State/province [23] 0 0
Athens
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Greece
State/province [24] 0 0
Thessaloniki
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Greece
State/province [25] 0 0
Tripoli
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Mexico
State/province [26] 0 0
Mexico
Country [27] 0 0
Mexico
State/province [27] 0 0
Yucatan
Country [28] 0 0
Peru
State/province [28] 0 0
Lima
Country [29] 0 0
Peru
State/province [29] 0 0
San Borja
Country [30] 0 0
Romania
State/province [30] 0 0
Bucharest
Country [31] 0 0
Romania
State/province [31] 0 0
Galati
Country [32] 0 0
Romania
State/province [32] 0 0
Iasi
Country [33] 0 0
Romania
State/province [33] 0 0
Magura
Country [34] 0 0
South Africa
State/province [34] 0 0
Benoni
Country [35] 0 0
South Africa
State/province [35] 0 0
Cape Town
Country [36] 0 0
South Africa
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Durban
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South Africa
State/province [37] 0 0
Pretoria
Country [38] 0 0
Turkey
State/province [38] 0 0
Gaziantep
Country [39] 0 0
Turkey
State/province [39] 0 0
Istanbul
Country [40] 0 0
Turkey
State/province [40] 0 0
Manisa

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT00119652
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca Seroquel Medical Science Director, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00119652