Seroquel in Bipolar Depression Versus Lithium

January 3, 2013 updated by: AstraZeneca

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

672

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Research Site
    • Nova Scotia
      • Sydney, Nova Scotia, Canada
        • Research Site
    • Ontario
      • Markham, Ontario, Canada
        • Research Site
      • Mississauga, Ontario, Canada
        • Research Site
      • Orleans, Ontario, Canada
        • Research Site
      • Sudbury, Ontario, Canada
        • Research Site
      • Waterloo, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
      • Sherbrooke, Quebec, Canada
        • Research Site
  • Croatia
      • Osijek, Croatia
        • Research Site
      • Split, Croatia
        • Research Site
      • Zadar, Croatia
        • Research Site
      • Zagreb-Susedgrad, Croatia
        • Research Site
  • Estonia
      • Kohtla-Jarve, Estonia
        • Research Site
      • Tallinn, Estonia
        • Research Site
      • Tartu, Estonia
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • Würzburg, Germany
        • Research Site
  • Indonesia
      • Jakarta, Indonesia
        • Research Site
      • Lawang, Indonesia
        • Research Site
    • Java
      • Solo, Java, Indonesia
        • Research Site
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
  • Latvia
      • Daugavpils, Latvia
        • Research Site
      • Riga, Latvia
        • Research Site
  • Lithuania
      • Kaunas, Lithuania
        • Research Site
      • Siauliai, Lithuania
        • Research Site
      • Vilnius, Lithuania
        • Research Site
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Research Site
      • Kuching Sarawak, Malaysia
        • Research Site
      • Petaling Jaya, Malaysia
        • Research Site
  • Norway
      • Brattvag, Norway
        • Research Site
      • Drammen, Norway
        • Research Site
      • Fredrikstad, Norway
        • Research Site
      • Mysen, Norway
        • Research Site
      • Paradis, Norway
        • Research Site
  • Philippines
      • Davao, Philippines
        • Research Site
      • Iloilo, Philippines
        • Research Site
      • Mandaluyong City, Philippines
        • Research Site
      • Manila, Philippines
        • Research Site
  • Poland
      • Bialystok, Poland
        • Research Site
      • Bydgoszcz, Poland
        • Research Site
      • Gdynia, Poland
        • Research Site
      • Leszno, Poland
        • Research Site
      • Lodz, Poland
        • Research Site
      • Skorzewo, Poland
        • Research Site
      • Wroclaw, Poland
        • Research Site
      • Zabrze, Poland
        • Research Site
  • Russian Federation
      • Arkhangelsk, Russian Federation
        • Research Site
      • Kazan, Russian Federation
        • Research Site
      • Lipetsk, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • Nizhniy Novgorod, Russian Federation
        • Research Site
      • Rostov-on-Don, Russian Federation
        • Research Site
      • Saratov, Russian Federation
        • Research Site
      • Smolensk, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site
      • Stavropol, Russian Federation
        • Research Site
      • Tver, Russian Federation
        • Research Site
      • Yaroslavl, Russian Federation
        • Research Site
  • Serbia
      • Belgrade, Serbia
        • Research Site
      • Cacak, Serbia
        • Research Site
      • Kragujevac, Serbia
        • Research Site
      • Niš, Serbia
        • Research Site
      • Valjevo, Serbia
        • Research Site
  • Taiwan
      • Changhua, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Research Site
      • Donetsk, Ukraine
        • Research Site
      • Kharkiv, Ukraine
        • Research Site
      • Kiev, Ukraine
        • Research Site
      • Lugansk, Ukraine
        • Research Site
      • Lviv, Ukraine
        • Research Site
      • Odessa, Ukraine
        • Research Site
      • Simferopol, Ukraine
        • Research Site
      • Vinnitsa, Ukraine
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
MADRS total score response
MADRS total score remission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Completion (ACTUAL)

May 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 21, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 4, 2013

Last Update Submitted That Met QC Criteria

January 3, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1447C00001
  • EMBOLDEN I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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