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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.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01145755
First received: May 27, 2010
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01145755

Locations
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
Study Chair: Richard Malamut AstraZeneca
Principal Investigator: Lora McGill CNS Healthcare
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Antidepressive Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014