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Trial record 44 of 158 for:    Diseases | ( Map: Costa Rica )

Seroquel in Bipolar Depression Versus SSRI (EMBOLDEN II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00119652
Recruitment Status : Completed
First Posted : July 14, 2005
Last Update Posted : January 4, 2013
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE July 6, 2005
First Posted Date  ICMJE July 14, 2005
Last Update Posted Date January 4, 2013
Study Start Date  ICMJE May 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
Change from baseline to Week 8 assessment in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS)
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00119652 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2006)
  • Secondary variables supportive to the primary objective:
  • MADRS total score response
  • MADRS total score remission
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Seroquel in Bipolar Depression Versus SSRI
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Bipolar Depression
  • Depression
Intervention  ICMJE
  • Drug: quetiapine fumarate (Seroquel)
  • Drug: paroxetine
  • Behavioral: mood stabilizing activity
Study Arms  ICMJE Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2007)
676
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Costa Rica,   Australia,   Chile,   Colombia,   Greece,   Mexico,   Peru,   Romania,   South Africa,   Turkey,   United States
Removed Location Countries United Kingdom,   Venezuela
 
Administrative Information
NCT Number  ICMJE NCT00119652
Other Study ID Numbers  ICMJE D1447C00134
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AstraZeneca Seroquel Medical Science Director, MD AstraZeneca
PRS Account AstraZeneca
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP