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

Major Depressive Disorder Clinical Trial

— AMBER  

Official title:

A Multi-Centre, Double-Blind, Randomised, Parallel Group, Placebo- Controlled and Active Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) as Mono- Therapy in the Treatment of Adult Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00351169
• Other study ID #: D1448C00004
• Secondary ID: AMBEREUDRACT No:
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2006
• Last updated: December 18, 2008
• Start date: May 2006
• Est. completion date: June 2007

Study information

• Verified date: December 2007
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female aged 18 to 65 years

• A documented diagnosis of major depressive disorder

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 the patient's current psychiatric status

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Quetiapine SR

• Escitalopram

Locations

Country	Name	City	State
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Gatineau	Quebec
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Kelowna	British Columbia
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Oakville	Ontario
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Penticton	British Columbia
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Sudbury	Ontario
Canada	Research Site	Sydney	Nova Scotia
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
China	Research Site	Beijing
China	Research Site	Ha Erbing
China	Research Site	Nanjing
China	Research Site	Shanghai
China	Research Site	Wu Han
Finland	Research Site	Helsinki
Finland	Research Site	Oulu
Finland	Research Site	Tampere
Finland	Research Site	Turku
Korea, Republic of	Research Site	Seoul
Malaysia	Research Site	Johor Bahru
Malaysia	Research Site	Perak
Malaysia	Research Site	Petaling Jaya
Mexico	Research Site	Aguascalientes
Mexico	Research Site	Distrito Federal
Mexico	Research Site	Guadalajara
Philippines	Research Site	Cebu City
Philippines	Research Site	Davao City
Philippines	Research Site	Mandaluyong City
Philippines	Research Site	Manila
South Africa	Research Site	Benoni
South Africa	Research Site	Cape Town
South Africa	Research Site	Durban
South Africa	Research Site	Johannesburg
South Africa	Research Site	Krugersdorp
Spain	Research Site	Sama de Langreo
Spain	Research Site	Vigo
Spain	Research Site	Zamora

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Canada,  China,  Finland,  Korea, Republic of,  Malaysia,  Mexico,  Philippines,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of quetiapine SR compared with placebo in the treatment of patients with major depressive disorder (MDD) as assessed by change from randomisation to week 8 score in the MADRS total score.
Secondary	If quetiapine SR improves health-related quality of life of patients with MDD, compared to placebo

External Links

•   AstraZeneca Clinical Trial Information - Outside US