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

Primary Purpose

Major Depressive Disorder

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AZD2066
Placebo
Duloxetine
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
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  • Research Site
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  • Research Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

AZD2066

Placebo

Duloxetine

Arm Description

Duloxetine

Outcomes

Primary Outcome Measures

MADRS Total Score Change From Baseline to Week 6
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
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
A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6

Full Information

First Posted
May 27, 2010
Last Updated
September 27, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01145755
Brief Title
6-week Study Treatment to Evaluate the Safety and Effectiveness of AZD2066 in Patients With Major Depressive Disorder
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AZD2066
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Duloxetine
Arm Type
Active Comparator
Arm Description
Duloxetine
Intervention Type
Drug
Intervention Name(s)
AZD2066
Intervention Description
18 mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Description
60 mg once daily
Primary Outcome Measure Information:
Title
MADRS Total Score Change From Baseline to Week 6
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
MADRS Response
Description
A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score.
Time Frame
6 weeks
Title
MADRS Remission
Description
A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Malamut
Organizational Affiliation
AstraZeneca
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lora McGill
Organizational Affiliation
CNS Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Garden Grove
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Rockville
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Cedarhurst
State/Province
New York
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Friendswood
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Bellevue
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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