AZD7268 safety and tolerability study
Study identifier:D1151C00005
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Major depressive disorder
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD7268, Escitalopram, Placebo capsules, Placebo tablets
Sex
All
Actual Enrollment
247
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Nov 2009
Primary Completion Date: 01 Apr 2010
Study Completion Date: 01 Apr 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 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. | Drug: AZD7268 15 mg, oral, twice daily (BID) Drug: Placebo tablets Placebo tablets to match encapsulated escitalopram |
| Placebo Comparator: 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. | Drug: Placebo capsules Placebo capsules to match AZD7268 Drug: Placebo tablets Placebo tablets to match encapsulated escitalopram |
| Active Comparator: 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. | Drug: Escitalopram 20 mg, oral, once daily (QD) Drug: Placebo capsules Placebo capsules to match AZD7268 |
