Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
247 participants
INTERVENTIONAL
2009-11-30
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AZD7268
The AZD7268 15 mg BID arm consisted of 3 AZD7268 5 mg capsules dosed orally in the morning and evening. In addition, 2 placebo tablets to match encapsulated escitalopram tablets were dosed orally in the morning only.
AZD7268
15 mg, oral, twice daily (BID)
Placebo tablets
Placebo tablets to match encapsulated escitalopram
Placebo
The placebo arm consisted of 3 placebo capsules to match AZD7268 capsules dosed orally in the morning and evening. In addition, 2 placebos to match encapsulated escitalopram tablets were dosed orally in the morning only.
Placebo capsules
Placebo capsules to match AZD7268
Placebo tablets
Placebo tablets to match encapsulated escitalopram
Escitalopram
The escitalopram 20 mg QD arm consisted of 3 placebo to match AZD7268 capsules dosed orally in the morning and evening. In addition, during Week 1, one encapsulated 10-mg escitalopram tablet and 1 placebo to match encapsulated escitalopram tablet were dosed orally in the morning only. During Weeks 2 through 4, two encapsulated 10-mg escitalopram tablets were dosed orally in the morning only.
Escitalopram
20 mg, oral, once daily (QD)
Placebo capsules
Placebo capsules to match AZD7268
Interventions
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AZD7268
15 mg, oral, twice daily (BID)
Escitalopram
20 mg, oral, once daily (QD)
Placebo capsules
Placebo capsules to match AZD7268
Placebo tablets
Placebo tablets to match encapsulated escitalopram
Eligibility Criteria
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Inclusion Criteria
* Documented primary clinical diagnosis meeting criteria from the DSM-IV, Text Revision (APA 2000) for any of the following:
* 296.2x Major Depressive Disorder, Single Episode, or
* 296.3x Major Depressive Disorder, Recurrent
Exclusion Criteria
* 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 started less than 4 weeks before enrollment
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Garden Grove, California, United States
Research Site
San Diego, California, United States
Research Site
New Haven, Connecticut, United States
Research Site
Bradenton, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Rockville, Maryland, United States
Research Site
Cedarhurst, New York, United States
Research Site
New York, New York, United States
Research Site
Rochester, New York, United States
Research Site
Dayton, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Memphis, Tennessee, United States
Research Site
Friendswood, Texas, United States
Research Site
Bellevue, Washington, United States
Research Site
Seattle, Washington, United States
Countries
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Other Identifiers
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D1151C00005
Identifier Type: -
Identifier Source: org_study_id
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