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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00351169
First received: July 11, 2006
Last updated: December 18, 2008
Last verified: December 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
 Drug: Quetiapine SR
Drug: Escitalopram
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • If quetiapine SR improves health-related quality of life of patients with MDD, compared to placebo

Estimated Enrollment: 450
Study Start Date: May 2006
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00351169

  Show 42 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Willie Earley, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00351169     History of Changes
Other Study ID Numbers: D1448C00004, AMBER, EUDRACT No: 2005-005052-40
Study First Received: July 11, 2006
Last Updated: December 18, 2008
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by AstraZeneca:
Major Depressive Disorder
MDD

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Citalopram
Dexetimide
Quetiapine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiparkinson Agents
 Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antipsychotic Agents

ClinicalTrials.gov processed this record on May 19, 2013