A Study to Assess the Effect and Safety of AZD6765 in Patients With Major Depressive Disorder



Status:Completed
Conditions:Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 70
Updated:4/12/2017
Start Date:December 16, 2011
End Date:August 26, 2013

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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

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 the N-methyl-D-aspartate (NMDA) class of glutamate receptors.

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

Inclusion Criteria:

- 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 Criteria:

- 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.
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