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

Major Depressive Disorder Clinical Trial

— ONYX  

Official title:

A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major Depressive Disorder With Inadequate Response to an Antidepressant Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00351910
• Other study ID #: D1448C00007
• Secondary ID: ONYXEUDRACT No:
• Status: Completed
• Phase: Phase 3
• First received: July 12, 2006
• Last updated: January 25, 2011
• Start date: May 2006
• Est. completion date: April 2007

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPAustralia: Department of Health and Ageing Therapeutic Goods AdministrationCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesNorway: Norwegian Medicines AgencyPoland: Ministry of HealthSouth Africa: Medicines Control CouncilSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy of quetiapine fumarate sustained release (Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with 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: 494
• Est. completion date: April 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 (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Quetiapine

• Amitriptyline

• Bupropion

• Citalopram

• Duloxetine

• Escitalopram

• Fluoxetine

• Paroxetine

• Sertraline

• Venlafaxine

Locations

Country	Name	City	State
Australia	Research Site	Brisbane
Australia	Research Site	Everton Park	Queensland
Australia	Research Site	Frankston	Victoria
Australia	Research Site	Malvern	Victoria
Australia	Research Site	Prahran	Victoria
Australia	Research Site	Richmond	Victoria
Australia	Research Site	Southport	Queensland
Belgium	Research Site	Assebroek
Belgium	Research Site	Brussels
Belgium	Research Site	Gent
Belgium	Research Site	Kortrijk
Belgium	Research Site	Liege
Belgium	Research Site	Mechelen
Belgium	Research Site	Tielt
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Moncton	New Brunswick
Canada	Research Site	Mount Pearl	Newfoundland and Labrador
Canada	Research Site	Pointe-claire	Quebec
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Toronto	Ontario
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Havirov
Czech Republic	Research Site	Havlickuv Brod
Czech Republic	Research Site	Nove Mesto nad Metuji
Czech Republic	Research Site	Olomouc
Czech Republic	Research Site	Ostrava
Czech Republic	Research Site	Praha 10
Czech Republic	Research Site	Praha 5
Czech Republic	Research Site	Praha 8
Finland	Research Site	Helsinki
Finland	Research Site	Jarvenpaa
Finland	Research Site	Salo
Finland	Research Site	Turku
France	Research Site	Angouleme
France	Research Site	Arcachon
France	Research Site	Caen
France	Research Site	Chateau Gontier
France	Research Site	Elancourt
France	Research Site	Le Pecq
France	Research Site	Nimes
France	Research Site	Paris
France	Research Site	Rennes
France	Research Site	Toulouse
Germany	Research Site	Augsburg
Germany	Research Site	Berlin
Germany	Research Site	Koln
Germany	Research Site	Munster
Norway	Research Site	Bergen
Norway	Research Site	Flekkefjord
Norway	Research Site	Fyllingsdalen
Norway	Research Site	Hamar
Norway	Research Site	Lysaker
Norway	Research Site	Oslo
Norway	Research Site	Skien
Poland	Research Site	Gdansk
Poland	Research Site	Lodz
Poland	Research Site	Nowy Targ
Poland	Research Site	Szczecin
Poland	Research Site	Torun
Poland	Research Site	Warszawa
Romania	Research Site	Bucharest
Romania	Research Site	Pitesti
South Africa	Research Site	Cape Town	Western Cape
South Africa	Research Site	Durban	Kwazulu-Natal
South Africa	Research Site	Pretoria	Gauteng
Sweden	Research Site	Falkoping
Sweden	Research Site	Göteborg
Sweden	Research Site	Halmstad
Sweden	Research Site	Malmo
Sweden	Research Site	Stockholm
Sweden	Research Site	Sundsvall
Sweden	Research Site	Trollhattan
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  Belgium,  Canada,  Czech Republic,  Finland,  France,  Germany,  Norway,  Poland,  Romania,  South Africa,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of quetiapine fumarate sustained release
Primary	(Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with Major Depressive Disorder.
Secondary	If quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone.

External Links

•   AstraZeneca Clinical Trial Information - Outside US