Status:
COMPLETED
A Study to Assess the Effect and Safety of AZD6765 in Patients With Major Depressive Disorder
Lead Sponsor:
AstraZeneca
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the effect and safety of AZD6765 in patients with major depressive disorder who exhibit inadequate response to antidepressants. AZD6765 is a channel blocker of t...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent before initiation of any study-related procedures.
- Male or female patients aged 18 to 70 years, inclusive.
- The patient must have a clinical diagnosis of major depressive disorder with a lifetime history of inadequate response to at least 3 antidepressants.
- Women of child-bearing potential must have a negative serum pregnancy test and confirmed use of a highly effective form of birth control before enrollment for a minimum of 3 months before study start.
- Outpatient status at screening and randomization visits.
Exclusion
- Patients with a history of diagnosed bipolar disorder or schizophrenia or schizoaffective disorder or currently exhibiting psychotic features associated with their depression; dementia or suspicion thereof.
- Patients who have had a suicide attempt within the last 6 months.
- Electroconvulsive therapy (ECT), vagal nerve stimulation (VNS) or transcranial magnetic stimulation (TMS) or previous treatment with ketamine infusion within the 6 months prior to screening, or any history of deep brain stimulation.
- Patients with any history of seizure disorder (except for febrile seizures in childhood).
- Pregnancy or lactation.
Key Trial Info
Start Date :
December 16 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2013
Estimated Enrollment :
542 Patients enrolled
Trial Details
Trial ID
NCT01482221
Start Date
December 16 2011
End Date
August 26 2013
Last Update
April 11 2017
Active Locations (44)
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1
Research Site
Chino, California, United States
2
Research Site
Lond Beach, California, United States
3
Research Site
San Diego, California, United States
4
Research Site
Stanford, California, United States