Seroquel in Bipolar Depression Versus Lithium

NCT ID: NCT00206141

Last Updated: 2013-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

672 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar Disorder Bipolar Depression Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Seroquel Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Kelowna, British Columbia, Canada

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Sydney, Nova Scotia, Canada

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Greater Sudbury, Ontario, Canada

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Markham, Ontario, Canada

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Mississauga, Ontario, Canada

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Orléans, Ontario, Canada

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Waterloo, Ontario, Canada

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Montreal, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Osijek, , Croatia

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Split, , Croatia

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Zadar, , Croatia

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Zagreb-Susedgrad, , Croatia

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Kohtla-Järve, , Estonia

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Tallinn, , Estonia

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Tartu, , Estonia

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Berlin, , Germany

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Würzburg, , Germany

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Solo, Java, Indonesia

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Jakarta, , Indonesia

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Lawang, , Indonesia

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Daugavpils, , Latvia

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Riga, , Latvia

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Kaunas, , Lithuania

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Šiauliai, , Lithuania

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Vilnius, , Lithuania

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Kuala Lumpur, , Malaysia

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Kuching Sarawak, , Malaysia

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Petaling Jaya, , Malaysia

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Brattvåg, , Norway

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Drammen, , Norway

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Fredrikstad, , Norway

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Mysen, , Norway

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Paradis, , Norway

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Davao City, , Philippines

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Iloilo City, , Philippines

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Mandaluyong, , Philippines

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Manila, , Philippines

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Bialystok, , Poland

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Bydgoszcz, , Poland

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Gdynia, , Poland

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Leszno, , Poland

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Lodz, , Poland

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Skorzewo, , Poland

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Wroclaw, , Poland

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Zabrze, , Poland

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Arkhangelsk, , Russia

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Kazan', , Russia

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Lipetsk, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Rostov-on-Don, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Smolensk, , Russia

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Stavropol, , Russia

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Tver', , Russia

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Yaroslavl, , Russia

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Belgrade, , Serbia

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Čačak, , Serbia

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Kragujevac, , Serbia

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Niš, , Serbia

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Valjevo, , Serbia

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Gyeonggi-do, , South Korea

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Seoul, , South Korea

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Changhua, , Taiwan

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Taipei, , Taiwan

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Dnipropetrovsk, , Ukraine

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Donetsk, , Ukraine

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Kharkiv, , Ukraine

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Kiev, , Ukraine

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Luhansk, , Ukraine

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Lviv, , Ukraine

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Odesa, , Ukraine

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Simferopol, , Ukraine

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Vinnitsa, , Ukraine

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Countries

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Canada Croatia Estonia Germany Indonesia Latvia Lithuania Malaysia Norway Philippines Poland Russia Serbia South Korea Taiwan Ukraine

References

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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.

Reference Type DERIVED
PMID: 20122369 (View on PubMed)

Other Identifiers

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EMBOLDEN I

Identifier Type: -

Identifier Source: secondary_id

D1447C00001

Identifier Type: -

Identifier Source: org_study_id

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