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6-week Study Treatment to Evaluate the Safety and Effectiveness of AZD2066 in Patients With Major Depressive Disorder

This study has been terminated.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: May 27, 2010
Last updated: September 27, 2012
Last verified: September 2012
This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in patients with major depressive disorder.

Condition Intervention Phase
Major Depressive Disorder
Drug: AZD2066
Drug: Placebo
Drug: Duloxetine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, Parallel Group Study to Assess the Effectiveness and Safety of AZD2066 After 6 Weeks of Treatment in Patients With Major Depressive Disorder - D0475C00020

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • MADRS Total Score Change From Baseline to Week 6 [ Time Frame: 6 weeks ]
    Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms.

Secondary Outcome Measures:
  • MADRS Response [ Time Frame: 6 weeks ]
    A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score.

  • MADRS Remission [ Time Frame: 6 weeks ]
    A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6

Enrollment: 131
Study Start Date: May 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD2066 Drug: AZD2066
18 mg once daily
Placebo Comparator: Placebo Drug: Placebo
Active Comparator: Duloxetine
Drug: Duloxetine
60 mg once daily

Detailed Description:
A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, parallel Group Study to Assess the Efficacy and Safety of AZD2066 after 6 weeks of treatment in Patients with Major Depressive Disorder - D0475C00020.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Provision of signed, written, and dated Informed Consent
  • Documented primary clinical diagnosis of Major Depressive Disorder

Exclusion Criteria:

  • Patients with a secondary psychiatric disorder including bipolar disorder, psychotic disorders (i.e. schizophrenia, schizoaffective disorder, depression with psychotic features), GAD and social anxiety disorder
  • Patients whose current episode of depression started less than 4 weeks before enrollment
  • History of inadequate response of antidepressants during current depressive episode
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01145755

United States, California
Research Site
Garden Grove, California, United States
Research Site
San Diego, California, United States
United States, Florida
Research Site
Jacksonville, Florida, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
United States, Maryland
Research Site
Rockville, Maryland, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, New York
Research Site
Cedarhurst, New York, United States
Research Site
Rochester, New York, United States
United States, Oregon
Research Site
Portland, Oregon, United States
United States, Tennessee
Research Site
Memphis, Tennessee, United States
United States, Texas
Research Site
Friendswood, Texas, United States
United States, Washington
Research Site
Bellevue, Washington, United States
Research Site
Seattle, Washington, United States
Sponsors and Collaborators
Study Chair: Richard Malamut AstraZeneca
Principal Investigator: Lora McGill CNS Healthcare
  More Information

Responsible Party: AstraZeneca Identifier: NCT01145755     History of Changes
Other Study ID Numbers: D0475C00020
Study First Received: May 27, 2010
Results First Received: August 28, 2012
Last Updated: September 27, 2012

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents processed this record on April 24, 2017