Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder

Last updated: December 18, 2008
Sponsor: AstraZeneca
Overall Status: Completed

Phase

3

Condition

Mood Disorders

Depression (Adult And Geriatric)

Depression

Treatment

N/A

Clinical Study ID

NCT00351169
D1448C00004
AMBER
EUDRACT No: 2005-005052-40
  • Ages 18-65
  • All Genders

Study Summary

To evaluate the efficacy and safety of quetiapine fumarate sustained release (Seroquel SR) in the treatment of Major Depressive Disorder.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female aged 18 to 65 years

  • A documented diagnosis of major depressive disorder

Exclusion

Exclusion Criteria:

  • Patients with a DSM IV Axis I disorder other than MDD within 6 months of enrolment

  • Patients with a diagnosis of DSM IV Axis II disorder which has a major impact on thepatient's current psychiatric status

  • Patients whose current episode of depression exceeds 12 months or is less than 4 weeksprior to enrolment

Study Design

Total Participants: 450
Study Start date:
May 01, 2006
Estimated Completion Date:
June 30, 2007

Connect with a study center

  • Research Site

    Edmonton, Alberta
    Canada

    Site Not Available

  • Research Site

    Kelowna, British Columbia
    Canada

    Site Not Available

  • Research Site

    Penticton, British Columbia
    Canada

    Site Not Available

  • Research Site

    Vancouver, British Columbia
    Canada

    Site Not Available

  • Research Site

    St. John's, Newfoundland and Labrador
    Canada

    Site Not Available

  • Research Site

    Halifax, Nova Scotia
    Canada

    Site Not Available

  • Research Site

    Sydney, Nova Scotia
    Canada

    Site Not Available

  • Research Site

    Hamilton, Ontario
    Canada

    Site Not Available

  • Research Site

    Oakville, Ontario
    Canada

    Site Not Available

  • Research Site

    Ottawa, Ontario
    Canada

    Site Not Available

  • Research Site

    Sudbury, Ontario
    Canada

    Site Not Available

  • Research Site

    Toronto, Ontario
    Canada

    Site Not Available

  • Research Site

    Gatineau, Quebec
    Canada

    Site Not Available

  • Research Site

    Montreal, Quebec
    Canada

    Site Not Available

  • Research Site

    Beijing,
    China

    Site Not Available

  • Research Site

    Ha Erbing,
    China

    Site Not Available

  • Research Site

    Nanjing,
    China

    Site Not Available

  • Research Site

    Shanghai,
    China

    Site Not Available

  • Research Site

    Wu Han,
    China

    Site Not Available

  • Research Site

    Helsinki,
    Finland

    Site Not Available

  • Research Site

    Oulu,
    Finland

    Site Not Available

  • Research Site

    Tampere,
    Finland

    Site Not Available

  • Research Site

    Turku,
    Finland

    Site Not Available

  • Research Site

    Seoul,
    Korea, Republic of

    Site Not Available

  • Research Site

    Johor Bahru,
    Malaysia

    Site Not Available

  • Research Site

    Perak,
    Malaysia

    Site Not Available

  • Research Site

    Petaling Jaya,
    Malaysia

    Site Not Available

  • Research Site

    Aguascalientes,
    Mexico

    Site Not Available

  • Research Site

    Distrito Federal,
    Mexico

    Site Not Available

  • Research Site

    Guadalajara,
    Mexico

    Site Not Available

  • Research Site

    Cebu City,
    Philippines

    Site Not Available

  • Research Site

    Davao City,
    Philippines

    Site Not Available

  • Research Site

    Mandaluyong City,
    Philippines

    Site Not Available

  • Research Site

    Manila,
    Philippines

    Site Not Available

  • Research Site

    Benoni,
    South Africa

    Site Not Available

  • Research Site

    Cape Town,
    South Africa

    Site Not Available

  • Research Site

    Durban,
    South Africa

    Site Not Available

  • Research Site

    Johannesburg,
    South Africa

    Site Not Available

  • Research Site

    Krugersdorp,
    South Africa

    Site Not Available

  • Research Site

    Sama de Langreo,
    Spain

    Site Not Available

  • Research Site

    Vigo,
    Spain

    Site Not Available

  • Research Site

    Zamora,
    Spain

    Site Not Available

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