AZD7268 Safety and Tolerability Study

Official Title: “A Phase IIa, 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”

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.

Intervention(s) in this Clinical Trial

• Drug: AZD7268
  • 3 capsules, oral, twice daily
• Drug: Escitalopram
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
  • AZD7268
• Placebo Comparator: Arm 2
  • Placebo capsules
• Active Comparator: Arm 3
  • Es citalopram

Primary Measures

• Change in the MADRS total score from baseline to Week 4
  • Time Frame: 1 per visit (6 visits)
    Safety Issue?: No

Secondary Measures

• MADRS response defined as ≥50% reduction in MADRS total score from baseline to Week 4
  • Time Frame: 1 per visit (6 visits)
    Safety Issue?: No
• Change in the HAM-D total score from baseline to Week 4
  • Time Frame: 1 per visit (6 visits)
    Safety Issue?: No
• Change in the HAM-A total score from baseline to Week 4
  • Time Frame: 1 per visit (6 visits)
    Safety Issue?: No

Inclusion Criteria:

• 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:
• 296.2x Major Depressive Disorder, Single Episode, or
• 296.3x Major Depressive Disorder, Recurrent

Exclusion Criteria:

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: AstraZeneca Industry

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01020799

Study ID Number: D1151C00005

ClinicalTrials.gov Identifier: NCT01020799

Health Authority: United States: Food and Drug Administration