AZD7268 Safety and Tolerability Study
A Phase II, Multi-center, Randomized, Double-bind, Double-dummy, Active and Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of AZD7268 in Patients With Major Depressive Disorder
1 other identifier
interventional
247
1 country
17
Brief Summary
The purpose of this study is to prove the principle that treatment with AZD7268 reduces depressive symptoms in patients with Major Depressive Disorder (MDD) compared with placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 major-depressive-disorder
Started Nov 2009
Shorter than P25 for phase_2 major-depressive-disorder
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 25, 2009
CompletedFirst Posted
Study publicly available on registry
November 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
April 10, 2012
CompletedApril 17, 2012
April 1, 2012
5 months
November 25, 2009
January 11, 2012
April 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Montgomery-Ă…sberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4.
MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). Change from baseline was calculated as Week 4 value minus baseline value. \[observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)\]
Baseline, Week 4
Secondary Outcomes (5)
Montgomery-Ă…sberg Depression Rating Scale (MADRS) Response
Week 4
Montgomery-Ă…sberg Depression Rating Scale (MADRS) Remission
Week 4
Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4.
Baseline, Week 4
Clinical Global Impression - Severity (CGI-S) Score Change From Baseline
Baseline, Week 4
Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline
Baseline, Week 4
Study Arms (3)
AZD7268
EXPERIMENTALThe 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.
Placebo
PLACEBO COMPARATORThe 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.
Escitalopram
ACTIVE COMPARATORThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- Provision of signed, written, and dated Informed Consent prior to any study specific procedures
- Documented primary clinical diagnosis meeting criteria from the DSM-IV, Text Revision (APA 2000) for any of the following:
- x Major Depressive Disorder, Single Episode, or
- x Major Depressive Disorder, Recurrent
You may not qualify if:
- Patients with a secondary DSM-IV Axis I disorder other than GAD or social anxiety disorder (as assessed by MINI), provided the primary diagnosis is MDD. This diagnosis should have been made at least 6 months before enrollment
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (17)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2009
First Posted
November 26, 2009
Study Start
November 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
April 17, 2012
Results First Posted
April 10, 2012
Record last verified: 2012-04