A study to assess the effect and safety of AZD6765 in patients with major depressive disorder
Study identifier:D6702C00031
ClinicalTrials.gov identifier:NCT01482221
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase IIb Efficacy and Safety Study of Adjunctive AZD6765 in Patients with Major Depressive Disorder (MDD) and a History of Inadequate Response to Antidepressants
Medical condition
Major depressive disorder
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD6765 iv, Placebo
Sex
All
Actual Enrollment
542
Study type
Interventional
Age
18 Years - 70 Years
Date
Study Start Date: 16 Dec 2011
Primary Completion Date: 26 Aug 2013
Study Completion Date: 26 Aug 2013
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2017 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 | Drug: AZD6765 iv 50 mg (AZD6765 Solution for Infusion, 0.5 mg/mL) by iv infusion. |
| Experimental: 2 | Drug: AZD6765 iv 100 mg (AZD6765 Solution for Infusion, 1.0 mg/mL) by iv infusion. |
| Placebo Comparator: 3 | Drug: Placebo 0.9 sodium chloride [normal saline] solution for injection by iv infusion |
Contacts
Investigators
Principal Investigator
Dhaval A Desai
1800 Concord Pike, Wilmington, DE 19850
