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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01145755
Recruitment Status : Terminated
First Posted : June 17, 2010
Results First Posted : September 27, 2012
Last Update Posted : October 3, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in patients with major depressive disorder.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: AZD2066 Drug: Placebo Drug: Duloxetine Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : May 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AZD2066 Drug: AZD2066
18 mg once daily
Placebo Comparator: Placebo Drug: Placebo
Active Comparator: Duloxetine
Duloxetine
 Drug: Duloxetine
60 mg once daily


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

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


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

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145755


Locations
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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
AstraZeneca
Investigators
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Study Chair: Richard Malamut AstraZeneca
Principal Investigator: Lora McGill CNS Healthcare
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01145755    
Other Study ID Numbers: D0475C00020
First Posted: June 17, 2010    Key Record Dates
Results First Posted: September 27, 2012
Last Update Posted: October 3, 2012
Last Verified: September 2012
Keywords provided by AstraZeneca:
Depression
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents