Seroquel in Bipolar Depression Versus SSRI
EMBOLDEN II
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)
1 other identifier
interventional
676
10 countries
54
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2005
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 6, 2005
CompletedFirst Posted
Study publicly available on registry
July 14, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedJanuary 4, 2013
January 1, 2013
July 6, 2005
January 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- Male and female out-patients aged 18 to 65 years inclusive
- Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II), most recent episode depressed
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (55)
Research Site
Phoenix, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
National City, California, United States
Research Site
San Clemente, California, United States
Research Site
San Diego, California, United States
Research Site
Maitland, Florida, United States
Research Site
Winter Park, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Smyrna, Georgia, United States
Research Site
Northfield, Illinois, United States
Research Site
Oak Brook, Illinois, United States
Research Site
New Orleans, Louisiana, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Glen Burnie, Maryland, United States
Research Site
St Louis, Missouri, United States
Research Site
Clementon, New Jersey, United States
Research Site
New York, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Dayton, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Irving, Texas, United States
Research Site
Richmond, Virginia, United States
Research Site
Bellevue, Washington, United States
Research Site
Kirkland, Washington, United States
Research Site
Brisbane, Queensland, Australia
Research Site
Everton Park, Queensland, Australia
Research Site
Southport, Queensland, Australia
Research Site
Epping, Victoria, Australia
Research Site
Malvern, Victoria, Australia
Research Site
Providencia Santiago, Chile
Research Site
Santiago, Chile
Research Site
Bogotá, Colombia
Research Site
San José, Costa Rica
Research Site
Athens, Greece
Research Site
Thessaloniki, Greece
Research Site
Tripoli, Greece
Research Site
México, Mexico
Research Site
Yucatán, Mexico
Research Site
Lima, Peru
Research Site
San Borja, Peru
Research Site
Bucharest, Romania
Research Site
Galati, Romania
Research Site
Iași, Romania
Research Site
Măgura, Romania
Research Site
Benoni, South Africa
Research Site
Cape Town, South Africa
Research Site
Durban, South Africa
Research Site
Pretoria, South Africa
Research Site
Gaziantep, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)
Research Site
Manisa, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 20122366DERIVED
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
July 6, 2005
First Posted
July 14, 2005
Study Start
May 1, 2005
Study Completion
May 1, 2007
Last Updated
January 4, 2013
Record last verified: 2013-01