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Seroquel in Bipolar Depression Versus Lithium

Primary Purpose

Bipolar Disorder, Bipolar Depression, Depression

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar disorder, bipolar depression, depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

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Outcomes

Primary Outcome Measures

The change from randomization to Week 8 assessment in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.

Secondary Outcome Measures

MADRS total score response
MADRS total score remission

Full Information

First Posted
September 13, 2005
Last Updated
January 3, 2013
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00206141
Brief Title
Seroquel in Bipolar Depression Versus Lithium
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Bipolar Depression, Depression
Keywords
Bipolar disorder, bipolar depression, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
672 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)
Primary Outcome Measure Information:
Title
The change from randomization to Week 8 assessment in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
Secondary Outcome Measure Information:
Title
MADRS total score response
Title
MADRS total score remission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Seroquel Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Kelowna
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Sydney
State/Province
Nova Scotia
Country
Canada
Facility Name
Research Site
City
Markham
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Orleans
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Sudbury
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Waterloo
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Osijek
Country
Croatia
Facility Name
Research Site
City
Split
Country
Croatia
Facility Name
Research Site
City
Zadar
Country
Croatia
Facility Name
Research Site
City
Zagreb-Susedgrad
Country
Croatia
Facility Name
Research Site
City
Kohtla-Jarve
Country
Estonia
Facility Name
Research Site
City
Tallinn
Country
Estonia
Facility Name
Research Site
City
Tartu
Country
Estonia
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Würzburg
Country
Germany
Facility Name
Research Site
City
Solo
State/Province
Java
Country
Indonesia
Facility Name
Research Site
City
Jakarta
Country
Indonesia
Facility Name
Research Site
City
Lawang
Country
Indonesia
Facility Name
Research Site
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Daugavpils
Country
Latvia
Facility Name
Research Site
City
Riga
Country
Latvia
Facility Name
Research Site
City
Kaunas
Country
Lithuania
Facility Name
Research Site
City
Siauliai
Country
Lithuania
Facility Name
Research Site
City
Vilnius
Country
Lithuania
Facility Name
Research Site
City
Kuala Lumpur
Country
Malaysia
Facility Name
Research Site
City
Kuching Sarawak
Country
Malaysia
Facility Name
Research Site
City
Petaling Jaya
Country
Malaysia
Facility Name
Research Site
City
Brattvag
Country
Norway
Facility Name
Research Site
City
Drammen
Country
Norway
Facility Name
Research Site
City
Fredrikstad
Country
Norway
Facility Name
Research Site
City
Mysen
Country
Norway
Facility Name
Research Site
City
Paradis
Country
Norway
Facility Name
Research Site
City
Davao
Country
Philippines
Facility Name
Research Site
City
Iloilo
Country
Philippines
Facility Name
Research Site
City
Mandaluyong City
Country
Philippines
Facility Name
Research Site
City
Manila
Country
Philippines
Facility Name
Research Site
City
Bialystok
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
Country
Poland
Facility Name
Research Site
City
Gdynia
Country
Poland
Facility Name
Research Site
City
Leszno
Country
Poland
Facility Name
Research Site
City
Lodz
Country
Poland
Facility Name
Research Site
City
Skorzewo
Country
Poland
Facility Name
Research Site
City
Wroclaw
Country
Poland
Facility Name
Research Site
City
Zabrze
Country
Poland
Facility Name
Research Site
City
Arkhangelsk
Country
Russian Federation
Facility Name
Research Site
City
Kazan
Country
Russian Federation
Facility Name
Research Site
City
Lipetsk
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
Research Site
City
Rostov-on-Don
Country
Russian Federation
Facility Name
Research Site
City
Saratov
Country
Russian Federation
Facility Name
Research Site
City
Smolensk
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Stavropol
Country
Russian Federation
Facility Name
Research Site
City
Tver
Country
Russian Federation
Facility Name
Research Site
City
Yaroslavl
Country
Russian Federation
Facility Name
Research Site
City
Belgrade
Country
Serbia
Facility Name
Research Site
City
Cacak
Country
Serbia
Facility Name
Research Site
City
Kragujevac
Country
Serbia
Facility Name
Research Site
City
Niš
Country
Serbia
Facility Name
Research Site
City
Valjevo
Country
Serbia
Facility Name
Research Site
City
Changhua
Country
Taiwan
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Research Site
City
Donetsk
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
Country
Ukraine
Facility Name
Research Site
City
Kiev
Country
Ukraine
Facility Name
Research Site
City
Lugansk
Country
Ukraine
Facility Name
Research Site
City
Lviv
Country
Ukraine
Facility Name
Research Site
City
Odessa
Country
Ukraine
Facility Name
Research Site
City
Simferopol
Country
Ukraine
Facility Name
Research Site
City
Vinnitsa
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
20122369
Citation
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.
Results Reference
derived

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Seroquel in Bipolar Depression Versus Lithium

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