Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder - AMETHYST

Study identifier:D1448C00005

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multi-Centre, Double-Blind, Randomised-Withdrawal, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR™) As Monotherapy in the Maintenance Treatment of Patients with Major Depressive Disorder

Medical condition

Major depressive disorder

Phase

Phase 3

Healthy volunteers

Study drug

Quetiapine Fumarate Sustained Release

Sex

All

Actual Enrollment

3000

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Dec 2005

Primary Completion Date: -

Study Completion Date: 01 Aug 2007

Study design

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

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Ottawa, ON, Canada

Location

Research Site

Quebec, QC, Canada

Location

Research Site

Montreal, Quebec, Canada

Location

Research Site

Gatineau, QC, Canada

Location

Research Site

Miramichi, NB, Canada

Location

Research Site

Vancouver, BC, Canada

Location

Research Site

Burlington, ON, Canada

Location

Research Site

Sherbrooke, QC, Canada

Arms	Assigned Interventions

Documents available

AstraZeneca Clinical Trial Information – Outside US
Download
https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1786&filename=CSR-D1448C00005.pdf
Download
CSR-D1448C00005.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Information, (US - 8a-7p EST)

800-236-9933

information.center@astrazeneca.com

Contact Backup

Outside US

001-800-236-9933

Investigators

Principal Investigator

AstraZeneca Seroquel Medical Science Director

AstraZeneca

Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder - AMETHYST

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Documents available

AstraZeneca Clinical Trial Information – Outside US

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1786&filename=CSR-D1448C00005.pdf

CSR-D1448C00005.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator