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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
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
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
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
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
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
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
State/province [18] 0 0
Washington
Country [19] 0 0
Chile
State/province [19] 0 0
Providencia Santiago
Country [20] 0 0
Chile
State/province [20] 0 0
Santiago
Country [21] 0 0
Colombia
State/province [21] 0 0
Bogota
Country [22] 0 0
Costa Rica
State/province [22] 0 0
San Jose
Country [23] 0 0
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
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South Africa
State/province [34] 0 0
Benoni
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South Africa
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Cape Town
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South Africa
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Durban
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South Africa
State/province [37] 0 0
Pretoria
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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00119652